MDSAP: CURRENT STATUS AND FUTURE PLANS
|
|
- Loreen Carter
- 6 years ago
- Views:
Transcription
1 MDSAP: CURRENT STATUS AND FUTURE PLANS Seminar hosted by DITTA in conjunction with IMDRF Monday, March Vancouver, BC, Canada
2 A few words about our friend Klaus Stitz:
3 MDSAP: CURRENT STATUS AND FUTURE PLANS OPENING REMARKS Patrick Hope Executive Director, MITA DITTA Chair Kimby Barton Interim Director of the Medical Devices Bureau, Health Canada
4 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 1: REGULATOR PERSPECTIVES Marc-Henri Winter Staff Fellow, MDSAP - Center for Devices and Radiological Health U.S. Food and Drug Administration Fabio Quintino Pereira Manager - Office of GMP Inspection Brazilian Health Regulatory Agency - ANVISA
5 Medical Device Single Audit Program Overview of the Program and its Mechanics Marc-Henri Winter, Staff Fellow FDA
6 Participants and Observers Participants Therapeutics Goods Administration (TGA) Agência Nacional de Vigilância Sanitária (ANVISA) Health Canada Observers World Health Organization (WHO) European Union MHLW* and PMDA** Food and Drug Administration (FDA) * Ministry of Health, Labor and Welfare ** Pharmaceuticals and Medical Device Agency 6
7 Operational Organization Regulatory Authority Council (RAC) MDSAP governing body: two senior managers from each participating jurisdiction. representation from observing jurisdictions. Subject Matter Experts (SME) Permanent or ad-hoc working groups to: Develop policies and documents. Develop tools. Implement the program. 7
8 Concept RA Assess and recognize AO Share audit reports Audit and certify Make regulatory decisions Mfr RA: Regulatory Authority; AO: Auditing Organization; Mfr: Manufacturer 8
9 Audit Criteria ISO ( ) Regulatory requirements on Quality Systems Brazilian Good Manufacturing Practices (ANVISA RDC 16). Japanese requirements (MHLW MO 169). FDA s Quality System Regulation (21 CFR Part 820). Specific national requirements on: Registration of manufacturer sites. Licensing of medical device. Reporting adverse event and advisory notices. Device tracking. 9
10 Audit Method MDSAP Audit Model 10
11 Audit Method Recently updated to Align with ISO 13485:2016. Add clarifications on the audit of technical documentation. Add clarification on the audit of sterile products. Training modules: For auditors: Articulate-online (including quiz). For all: on the FDA CDRH Learn webpage. ( 11
12 Audit Nonconformity (NC) Grading GHTF/SG3/N19:2012 Quality management system Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange. QMS Impact Direct: 3 Indirect: 1 Repeat NC Yes: 1 No: 0 Lack of Document Yes: 1 No: 0 Released Device Yes: 1 No: 0 NC Grade = sum of 4 parameters, capped at 5 12
13 AO Journey To Recognition Assessment Activity Application reviewed favorably Status Application Received Stage 1 + Stage 2 (+ Critical Locations) + Response to any nonconformity deemed acceptable 3 Witnessed Audits + Response to any nonconformity deemed Recognition Decision acceptable Authorized to conduct MDSAP audits (the first 3 to be witnessed) Recognized 13
14 Auditing Organizations Application Received Authorized to Conduct MDSAP Audits Recognized 14
15 Manufacturer Participation Required to maintain Canadian Device Licences after Voluntary and encouraged to - Register devices in Australia especially combination products. Obtain ANVISA GMP certificate devices class III and IV. Substitute to PMDA audits. Substitute routine FDA inspections any devices. 15
16 International Value of MDSAP Europe will determine whether to become a participating member of the MDSAP coalition and if/ how they can use the outcomes of the program. WHO Prequalification of in vitro diagnostics use MDSAP audits to abbreviate or waive WHO inspections. Others advocacy towards the use of MDSAP certificates by non-participating Regulatory Authorities. 16
17
18 MDSAP consortium: Current status, Timelines and Plans Fábio P. Quintino MDSAP RAC Chair Office of GMP Inspection for Medical Devices, Sanitizers and Cosmetics ANVISA-Brazil
19 CONTENT HISTORY STATUS PERSPECTIVES
20 HISTORY From GHTF, IMDRF launched at planning meeting in Ottawa in October 2011 where ToR was drafted Singapore meeting (March 2012) marked official inauguration of IMDRF One of the 5 inaugural work items
21 IMDRF MDSAP WG PURPOSE Develop standard set of requirements for auditing organizations performing regulatory audits of medical device manufacturers quality management systems Represented a critical step in establishing any Medical Device Single Audit Project
22 IMDRF MDSAP WG OUTCOME Documents for the Regulatory Authority assessments of AOs are based on: IMDRF/MDSAP WG /N5 FINAL:2013 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations IMDRF/MDSAP WG /N6 FINAL:2013 Regulatory Authority Assessor Competence and Training Requirements IMDRF/MDSAP WG/N8 FINAL:2015 Regulatory Authority Assessment Method Guidance IMDRF/MDSAP WG/N11 FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization
23 IMDRF MDSAP WG OUTCOME Recognition, monitoring and re-recognition of Auditing Organizations documents: IMDRF/MDSAP WG/N3FINAL:2013 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition IMDRF/MDSAP WG/N4FINAL:2013 Competence and Training Requirements for Auditing Organizations IMDRF/MDSAP WG/N24 MDSAP Audit Report Guidance
24 Timeline SoC 11/2012: Signature of the Statement of Cooperation for the development of a single audit program (TGA; ANVISA; HC; US FDA) 03/2013: Accelerated plan to develop the basic structure for the 3 year pilot program starting on 01/01/ /2015: Japan (MHLW/PMDA) announces their participation in the pilot 12/2016: End of the pilot Transition to operational phase
25 CURRENT STATUS
26 MDSAP RECOGNIZED AOs BSI Group America Inc. Intertek Testing Services NA Inc. TŰV SŰD America Inc. 26
27 AOs AUTHORIZED TO PERFORM MDSAP AUDITS DEKRA Certification B.V. DQS Medzinprodukte GmBH LNE G-MED SAI Global Cert. Services PTY Ltd. SGS United Kingdom Ltd. TŰV Rheinland of North America Inc. TŰV USA Inc. UL Medical and Regulatory Services, UL LCC
28 AOs UNDER AUTHORIZATION PROCESS Lloid s Registry Quality Assurance Inc. - LRQA National Standards Authority of Ireland NSAI NSA Health Sciences Certification, LLC
29 As in march 9th
30 AUDIT NUMBERS 164 MDSAP Audits Reports to date 46 audits noted no nonconformities 118 audits had at least 1 nonconformity
31 Plans and Perspectives
32 Perspectives Pilot report to be issued An expected fast grow of the program in the transitional phase poses challenges Resource allocation MDSAP business model implementation Establishment of new RA
33 Regulatory Exchange Platform secure (REPs) IT solution to facilitate the exchange of confidential/non-public information (NPI), as well as the collaboration of regulators in a secure IT environment Starting with MDSAP module Partners: ANVISA Brazil, Health Canada, MHLW/PMDA Japan, TGA - Australia, US FDA and PAHO (Pan American Health Organization) Development phase started on March years are estimated for completion
34 Perspectives Increase of the use of program outcomes by each RA, maximizing value Learning curve, process improvements and program scale up may allow cost reduction
35 Perspectives Consolidation as a global, effective and resource wise tool for the regulatory oversight of Medical Device Manufacturer s QMS implementation.
36 Thanks for your Attention
37 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 1: REGULATOR PERSPECTIVES Q&A
38 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 2: ASSESSING ORGANIZATION (AO) PERSPECTIVES Gary Minks Vice President, Quality & Regulatory Affairs TÜV SÜD America Inc. Patricia Murphy Global Head, MDSAP Program BSI Healthcare
39 DITTA Seminar MDSAP; An Auditing Organization s Perspective Gary Minks TÜV SÜD America Inc Office: Mobile: gminks@tuvam.com TÜV SÜD 14/03/2017 Corporate Presentation Slide 39
40 Our heritage: 150 years of business success Establishment of a Mannheim-based steam boiler inspection association by 22 operators and owners of steam boilers, with the objective of protecting man, the environment and property against technology-related risks First vehicle periodic technical inspection (PTI) 1926 Introduction of the TÜV mark / stamp in Germany 1958 Development of a Bavaria-wide network of vehicle inspection centers in the late 1950s 1990s Conglomeration of TÜVs from the southern part of Germany to form TÜV SÜD and the expansion of business operations into Asia 2006 Expansion of services in ASEAN by acquiring Singapore-based PSB Group 2009 Launch of Turkey-wide vehicle inspection by TÜVTURK Today TÜV SÜD continues to pursue a strategy of internationalisation and growth TÜV SÜD TÜV SÜD Corporate presentation Slide 40
41 Achieve market success Manufacturing & industrial machinery Consumer products & retail Healthcare & medical devices Telecommunications & IT Services for components manufacturers, contractors, installation providers, equipment & material manufacturers and operators include: Component testing Periodic inspection of equipment Failure analysis System certification Training Services for manufacturers, retailers, buyers and suppliers of electrical & electronics, food, health & beauty, hardlines, softlines, toys & children s products: Testing Auditing Inspection Product certification Knowledge services System certification Training Services for medical device manufacturers and healthcare providers include: Clinical approvals Market approvals and certification Testing Evaluation System certification Training Services for equipment manufacturers and operators of infrastructure equipment and radio frequency wireless equipment include: Design reviews Testing Software escrow Product certification System certification Training TÜV SÜD TÜV SÜD Corporate presentation Slide 41
42 MDSAP - Successes Auditor on-line training for MDSAP program requirements. We are quickly ramping up our global MDSAP auditor capaciity. Collaboration between Regulators and Auditing Organizations during the pilot program Manufacturers have avoided US FDA and Australian TGA inspections. Manufacturers have used MDSAP audit reports to obtain ANVISA GMP certificates. TUV SUD is conducting combined MDSAP / European MDD audits. TÜV SÜD America Slide 42
43 MDSAP - Challenges Auditor Mentoring is a challenge in these early audits (i.e., pairing experienced auditors with first time auditors) Coverage of all 94 core tasks and regulatory authority specific tasks while conducting a Process Audit. The Audit Model works but it takes some experience. The auditors that have done several MDSAP audits report that they do get more comfortable over time. Realign task numbers to more logically align with sequence of audits TÜV SÜD America Slide 43
44 MDSAP - Challenges Combining MDSAP with European MDD (Medical Device Directive) audits. Adding MDD requirements into the Audit Model would help. Surveillance audit man-days for small organizations Manufacturer s concern with regulator information sharing Some customers change their attitude with MDSAP compared to previous audits. Scoping of multiple site audits (i.e., which sites to include) 15 day limit for manufacturers to respond to nonconformities Obtaining the correct DUNS numbers from manufacturers TÜV SÜD America Slide 44
45 DITTA MDSAP - Current Status and Future Plans Auditing Organization Perspective Successes & Challenges Copyright 2017 BSI. All rights reserved 45 14/03/2017
46 Program Distinctions Criteria ISO MDSAP Program Customer Manufacturer Regulator Output of success Auditing Organizations Qualification Certificate Competent Body Report & Certificate Regulators Audit Duration Employee count Fixed Timing Nonconformance grading Major/Minor 1, 2, 3, 4, 5
47 Pilot Phase 2014 thru 2016 Program Launches Copyright 2017 BSI. All rights reserved 47 14/03/2017
48 Program Launch Program Challenges 1. Jurisdictional requirements Interaction with ISO Complexity of differences Inclusion of CE 2. Locations How they interact Where they are located 3. Adoption by manufacturers 4. Length of audit Sufficient resources Organization of audit plan 5. Reporting Active voice All jurisdictions Specific timelines NCR grading Copyright 2017 BSI. All rights reserved 48 14/03/2017
49 Pilot Phase thru 2016 Audit Model Challenges Auditors Task-based Not ISO Plus Deep Dive into processes Regulatory Audit Risk key part of audit Manufacturers Confused by delivery Single audit Consistent flow Product - focused Risk focus support Copyright 2017 BSI. All rights reserved 49 14/03/2017
50 Pilot Program Successes 1. Auditing organizations jumped into the program and encouraged manufacturers to engage 2. Manufacturers recognized cost benefit 3. AO s embraced regulatory audit model 4. Five jurisdictions engaged 5. All stakeholders adapting to be successful Copyright 2017 BSI. All rights reserved 50 14/03/2017
51 Operational Phase 2017 Program Evolves Copyright 2017 BSI. All rights reserved 51 14/03/2017
52 Program settling in Changes evolved through the Pilot and into Operational Phase 1. Audit task timeline changes 2. Campus location defined 3. Additional auditing organizations progressing through qualifications 4. Manufacturers engagement growing dramatically in 2017, despite low numbers in Pilot phase Copyright 2017 BSI. All rights reserved 52 14/03/2017
53 Operational Phase beyond 2017 Copyright 2017 BSI. All rights reserved 53 14/03/2017
54 Program future outlook 1. New jurisdictions engage 2. Current jurisdictions expand use of MDSAP audit for other approvals Copyright 2017 BSI. All rights reserved 54 14/03/2017
55 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 2: ASSESSING ORGANIZATION (AO) PERSPECTIVES Q&A
56 MDSAP: CURRENT STATUS AND FUTURE PLANS BREAK: 30 MINUTES Refreshments served in foyer
57 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 3: REGULATED INDUSTRY PERSPECTIVES MDSAP Industry Participation Survey: Findings
58 MDSAP INDUSTRY PARTICIPATION SURVEY: FINDINGS Presented at MDSAP: Current Status and Future Plans Seminar hosted by DITTA in conjunction with IMDRF Monday, March Patrick Hope MITA Executive Director; DITTA Chair
59 MDSAP INDUSTRY PARTICIPATION SURVEY INTRODUCTION Objective: Improve industry participation in MDSAP Goal: Widespread adoption and use of MDSAP Survey methodology: Conducted online January 15-February participants
60 MDSAP INDUSTRY PARTICIPATION SURVEY MAJOR THEMES Most respondents did NOT participate in MDSAP pilot Those that DID participate found value in the program
61 Most participants only signed up 1 facility/manufacturing site MDSAP INDUSTRY PARTICIPATION SURVEY MAJOR THEMES
62 although they are planning to add more MDSAP INDUSTRY PARTICIPATION SURVEY MAJOR THEMES
63 Overall experience of participants: POSITIVE! MDSAP INDUSTRY PARTICIPATION SURVEY MAJOR THEMES
64 55% did not attempt, deterred by cost or lack of interest 10.5% attempted, but deterred by issues with cost or AO MDSAP INDUSTRY PARTICIPATION SURVEY NON-PARTICIPANTS, EXPLAINED
65 MDSAP INDUSTRY PARTICIPATION SURVEY NON-PARTICIPANTS, EXPLAINED 34% report their decision not to participate was based on other, often complex factors However: none so complex that they can t be fixed!
66 MDSAP INDUSTRY PARTICIPATION SURVEY GENERAL INFORMATION Most survey respondents sell into all MDSAP countries
67 MDSAP INDUSTRY PARTICIPATION SURVEY GENERAL INFORMATION More of respondents business is covered by MDSAP than is not
68 MDSAP INDUSTRY PARTICIPATION SURVEY GENERAL INFORMATION Most respondents used US FDA s online resources
69 MDSAP INDUSTRY PARTICIPATION SURVEY GENERAL INFORMATION Most respondents reported that the survey touched all aspects of concern with MDSAP
70 MDSAP INDUSTRY PARTICIPATION SURVEY TAKEAWAYS & NEXT STEPS Survey respondents that participated in MDSAP liked it Those that did not participate were open or planning to participate in MDSAP in the future
71 MDSAP INDUSTRY PARTICIPATION SURVEY TAKEAWAYS & NEXT STEPS MDSAP success depends on: Regulators wide use MDSAP as total replacement for current QMS audits Auditors have sufficient capacity to carry out all MDSAP audits by deadline Industry has sufficient time for all facilities to undergo MDSAP audit
72 THANK YOU!
73 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 3: REGULATED INDUSTRY PERSPECTIVES Philip Steinborn Medtronic Emmett Deveraux Cook Medical Naoki Morooka Shimadzu Medical Systems Vijay Madikonda Johnson & Johnson Medical Devices
74 MEDTRONIC AND MDSAP Phil Steinborn VP, Quality/RA Americas
75 MDSAP IS HERE TO STAY MEDTRONIC IS COMMITTED TO PROGRAM 1. Achievements: Where are we with MDSAP? Challenges: What are the obstacles or risks as we see it? Suggestions: Our recommendations for industry and the program. 75
76 WHERE DO WE STAND WITH MDSAP? ACHIEVEMENTS 10+ FACILITIES ALREADY INSPECTED IN MDSAP PARTICIPATED IN PILOT PROGRAM NO OTHER INSPECTIONS AT MDSAP SITES TO DATE MDSAP CERTIFICATE ACCEPTED SEVERAL WITNESSED AUDITS. TO PERMIT AOs TO ATTAIN QUALIFICATION WORKING WITH MULTIPLE AOs SCHEDULING FOR OTHER FACILITIES PRIORITIZING CMDCAS SITES 76
77 WHAT ARE THE OBSTACLES OR RISKS? CHALLENGES CAPACITY OF PROGRAM CAN AOs MEET DEMAND? 4 AOs FULLY ACCREDITED 4 AOs IN WITNESSED AUDITS STAGE OF ACCREDITATION 5 AOs IN PRELIMINARY ASSESSMENT PROCESS DO AOs HAVE SUFFICIENT NUMBER OF MDSAP TRAINED AUDITORS? CAN WE GET TIMELY MDSAP AUDITS SCHEDULED? 77 COMPLEXITY OF AUDIT Significant preparation required. Audit to 5 different sets of regulations challenging. Annual inspection more frequent than usual for many of the participating regulators New process Experiencing some delays in getting audit reports can adversely impact registrations. Price tag for MDSAP audit significantly higher Are we saving with annual audits or does it balance out? RESPONSE FROM REGULATORS Regulators receiving annual MDSAP audit reports how will they react? FDA will treat Grade 4 and 5 findings as OAI (Official Action Indicated).. May result in Warning Letter. Regulators may send AOs back in to follow up on gaps in audit report (... or go themselves). Opportunity for regulators to uphold very particular requirements of their regulations.
78 OUR RECOMMENDATIONS FOR INDUSTRY AND PROGRAM SUGGESTIONS FOR INDUSTRY Prepare for the audits. Use the MDSAP Companion documents. Sticking points tend to be unique req ts of countries. Identify these! Engage AOs early. Get on their schedules and allow them to plan accordingly. Take AO findings seriously. Regulators are getting your reports. Don t forget about OEMs that are CMDCAS. They also need MDSAP. FOR PROGRAM Significant concerns about capacity. Availability of AOs and qualified auditors a real issue. Consider low risk manufacturers go to single surveillance over the 3 year cycle to help alleviate backlog. Current MDSAP model is not expandable. Audit is too complex with multiple sets of regulations. Need to align on a single audit standard (to meet local regulations) such as ISO 13485:
79 GOVERNMENT AFFAIRS Global Regulatory Developments An Industry Perspective on the Medical Device Single Audit Programme (MDSAP) COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
80 COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION.
81 Cook Medical s history with MDSAP Volunteered for the program in December First Inspection was in April, 2015 (Witnessed AO Inspection) Second MDSAP Inspection February 2016 (Non Witnessed) We believe we were one of the first in Europe and the first Irish Site. Two manufacturing sites in Europe but Ireland was chosen as the test site. Great Team at the Cook Ireland site and the success is down to them. COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
82 What this presentation is not going to be A detailed technical discussion on the Instead MDSAP it will be a very top level personal opinion of the MDSAP principle and achievements to-date COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION.
83 Overall comment Yes! Positive and to be welcomed COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
84 Like anything new there are some concerns. Capacity concerns within the Auditing Organisations. The expansion of the MDSAP Programme Full benefits to Industry, incl. SMEs, yet to be realised Full EU Participation COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
85 Capacity within the Auditing Organisations (AO) COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
86 How many trained MDSAP Inspectors does each AO have? COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
87 How many actual inspectors with the AOs with the MDSAP skill set? CLASS STERI CLINICAL MDD LOG ACTIVE COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
88 The Global Expansion of the MDSAP Programme. COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
89 Benefits for Industry yet to be fully realized It s a considerable expense so the benefits have to meet all expectations, incl SME s The principle is solid and its concept is one that industry and the patient will benefit from. The true benefit will come once the programme has developed and become truly global in nature. For now my advice is to stay involved but work with the Regulators to ensure that the benefits are realized for all stakeholders. COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
90 Full EU Participation? EU have decided not to join the full programme. Resource Issues Industry would encourage that the EU come on board as a full member COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
91 How did Industry respond to the MDSAP request for action? YOUR REGULATOR WANTS YOU! COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
92 Participating manufacturers (June 2016) COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
93 Overall score for Industry (My opinion) 5/10 We Passed but with much to do and to learn! COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
94 Why do I say that? IMDRF as you know replaced the GHTF model 5 years ago Industry comments on IMDRF have been consistent We need to be at the table and be more than just observers. IMDRF gave us this opportunity for MDSAP but unfortunately we were slow in joining the pilot. Lets learn from this and move on together. COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. GOVERNMENT AFFAIRS
95 Well done and please let it grow and expand and reach its full potential! COMPANY CONFIDENTIAL. DO NOT COPY. NOT FOR EXTERNAL DISTRIBUTION. CORP-D30444-EN GOVERNMENT AFFAIRS
96 Session 3 MDSAP Pilot Experience and Barriers to Participation in Japan Naoki Morooka Senior Manager, Quality Assurance Department Medical Systems Division, Shimadzu Corporation 13 March, 2017
97 Contents Introduction Consideration for implementation Steps for implementation Suggestion Additional Information of Speaker Naoki Morooka *SC member of DITTA *Chairman of QMS committee in JIRA. *Chairman of QMS committee in JFMDA. 97
98 Introduction - MDSAP Pilot in Japan Pilot stage in Japan 1 st Phase until 31 December nd Phase until 31 December 2018 For Approved Product Required documents by PMDA MDSAP report required for QMS inspection. Reduce the required documentation for Review by PMDA. For Certified Product Registered Certification Body also required to accept them. 98
99 Introduction -MDSAP Pilot in Japan Registered AOs Application Received Authorized to Conduct MDSAP Audits Recognition 13 organizations 11 organizations 3 organizations Almost AOs have local office in Japan. Ref.: List of AOs Implementation Japan into MDSAP pilot. Japanese QMS requirements were placed into Companion Document. And then, the auditors in AOs was trained according to Companion Document. PMDA received a few application for QMS inspection based on MDSAP report. Ref.: Companion Documents 99
100 Introduction -Company Profile and Certification Scope Company Profile Shimadzu Corporation Medical Systems Division Location: Kyoto, Japan Product/Certification Scope Diagnostic X-ray Devices Angiographic X-ray Diagnostic Systems Nuclear Medicine Diagnostic Systems Medical Image Managements Systems Near infrared fluorescence Imaging System(NIRS) Tumor-Tracking Systems for Radiotherapy Systems Certification/Auditing ISO13485:2003/ ISO9001 Angiography Systems Fluoroscopy Systems PET Scanner for Mammography Imaging CMDCAS, MDD Annex II, Japan-PMD Act MO169 All certifications were issued by same Certification Body. <Single Audit/ Multi-Certification/Report> US-FDA 21CFRpart 820, ANVISA, CFDA, etc. Audited by RA. General Radiography Systems Mobile X-ray Systems NIRS Systems Tumor-Tracking Systems for Radiotherapy Systems 100
101 Consideration Timing and Cycle for Certification Audit MDSAP Certification Audit For implementation of MDSAP, Certification Scope Extension was not considered in Audit Model. Full Audit required. Timing for Certification Audit Synchronize with existing Certification Cycles. in order to reduce the auditing cost. Transition period for Key Standards/Regulation MDSAP pilot 31 December ISO 9001: September CMDCAS 31 December ISO13485: February
102 Consideration Certification Cycles in our company Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Certification Audit Certification Audit Certification Audit Certification Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Certification Audit Certification Audit Certification Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Surveillance Audit Certification Audit ISO13485:2003 Cert. 3 years Cycle ISO13485:2016 Transition Period CMDCAS 3years Cycle MDSAP Transition Period ISO9001:2008 Cert. 3 years Cycle ISO9001:2015 Transition Period Surveilla Audit Our AO was not recognized yet Surveillance Audit Our Current Target Schedule Certification Audit Surveillance Audit Surveillance Audit MDSAP ISO13485:2016 ISO9001:2015 MDD or J-PMDAct 5years Cycle Surveillance Audit 102
103 Steps for implementation Steps Decision for schedule for Certification Audit as MDSAP Selection of AO Gap Analysis/Impact Assessments Modification/Adjustment for QMS Internal Audit Management Review Certification Audit by AO 103
104 Steps for implementation -Key elements Gap Analysis/Impact Assessments Details Audit Model MDSAP AU P Audit Model (PDF - 882KB) (ISO 13485:2003) MDSAP AU P Audit Model (PDF - 770KB) (ISO :2016) New Companion Document MDSAP AU G : Companion Document (PDF - 1.5MB) (ISO :2003) MDSAP AU G : Companion Document (PDF - 1.2MB) (ISO :2016) New Difference of Auditing Approach Top down approach Review for Subsystem (FDA-QSIT oriented) 104
105 Steps for implementation - key elements Sample description in Companion Document Chapter 1 - task 8. Verify that procedures have been defined, documented, and implemented for the control of documents and records of both internal and external origin required by the quality management system. Confirm the organization retains records and at least one obsolete copy of controlled documents for a period of time at least equivalent to the lifetime of the device, but not less than two years from the date of product release. Clause and Regulation: [ISO 13485:2016: 4.1.4, 4.2.1, 4.2.4, 4.2.5; TG(MD)R Sch3 P1 1.4(4); RDC ANVISA 16/2013: 3.1; MHLW MO169: 5, 6, 8, 9,; 21 CFR , ] Additional country-specific requirements: Australia (TGA): Confirm that Quality Management System documentation and records in relation to a device described in TG(MD)R Sch3 P1 1.9 are retained by the manufacturer for at least 5 years. Brazil (ANVISA): Verify that change records include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective [RDC ANVISA 16/2013: 3.1.5]. Japan (MHLW) Confirm that Quality Management System documentation and records in relation to a device are retained for the following. 105
106 Steps for implementation -Key elements Consideration for Reporting For Deviation, Grading system was applied according to GHTF/SG3/N19:2012 Nonconformity Step 1 Grading Matrix Step 2 Escalation Rules Final Nonconformity Grade Grading Overview Grading Matrix Ref: 106
107 Suggestion For Regulators Scope Extension Audit Scope Extension Audit for ISO13485 Certification was not considered in Audit Model. Implementation Guide for Manufacturer. Manufacturer might need Implementation Guide for Manufacturer for better understanding for MDSAP. For Regulators and AOs Capacity of AOs in 2018/2019? So many company will request certification audit in 2018 or Do AOs have capability for them? For Industry Benefit We are considering to reduce auditing by US-FDA and ANVISA. 107
108 Medical Device Single Audit Program (MDSAP) Ethicon Experience Vijay Kumar Madikonda Ethicon Compliance March 13, 2017
109 Agenda Ethicon Inc. Achievements Audit Experience & Challenges Suggestions/Feedback on the MDSAP Program Confidential For J&J Use Only 10 9
110 Achievements: MDSAP Pilot Update Ethicon and Mentor Business units of J&J participated in the MDSAP Pilot Program. Details of the sites piloted for the MDSAP are as follows: SITE Ethicon LLC, San Lorenzo Most recent MDSAP audit dates May 19-22, 2015 & Mar 15-18, 2016 Type of Audit Site Activities Product supply MDSAP Surveillance MDSAP Surveillance Manufacturer WW supply including US, Canada, Australia, Brazil & Japan Ethicon SARL, Neuchatel Aug 25-27, 2015 & June 28-July 1, 2016 Ethicon Inc., Somerville Dec 1-2, 2015 Jun 1-3, 2016 MDSAP Certification MDSAP Surveillance MDSAP Surveillance MDSAP Surveillance Manufacturer Design, Regulatory, PMS, Complaint handling WW supply including US, Canada, Australia, Brazil & Japan WW supply including US, Canada, Australia, Brazil & Japan Ethicon Inc., Durango, Juarez Jun 7-8, 2016 MDSAP Surveillance Manufacturer WW supply including US, Canada, Australia, Brazil & Japan Mentor Irving July 14-18, 2015 June 21-24, 2016 MDSAP Certification MDSAP Surveillance Design, RA, PMS, CQ, Mfg. WW supply including US, Canada, Australia, Brazil & Japan MDSAP Plans for 2017: Added 6 more Ethicon sites to the MDSAP program and inspections scheduled in Multiple J&J Medical device sites are moving into MDSAP program. Confidential For J&J Use Only 11 0
111 Audit Experience & Challenges Audit Process: Transparent and Task-based Audit Model follows Companion Document Very thorough audits and evaluated compliance to all regulations Audit Duration: Longer audit times No significant difference between Recertification and Surveillance audit time. Challenges: Challenges in scheduling of the Audits due to limited trained auditors. Review of some information not related to the site scope (design, complaint handling, Regulatory, Quality systems) required Franchise participation in each site audits. Confidential For J&J Use Only 11 1
112 Feedback on the MDSAP Program: Positive: Well trained auditing organizations conducting audits in a consistent way. Suggestions/Opportunities: Train more auditors to support full MDSAP implementation. Training materials and Guidance available of MDSAP website. Timely issuance of audit reports and MDSAP certificates. Reduction in the number of Audits & Less business disruption. Harmonization of requirements. Expand the scope of MDSAP acceptability to include For cause inspections as AO s can conduct Special audits to follow-up on Post market issues, significant findings from previous audits and based on request from participating regulatory authorities. Post audit timeline of D for providing evidence of implementation of remediation actions addressing Grade 4 or 5 observations is too short if robust actions are to be implemented. Confidential For J&J Use Only 11 2
113 Thank you Confidential For J&J Use Only 11 3
114 MDSAP: CURRENT STATUS AND FUTURE PLANS SESSION 3: REGULATED INDUSTRY PERSPECTIVES Q&A
115 MDSAP: CURRENT STATUS AND FUTURE PLANS CLOSING SESSION: PANEL DISCUSSION Moderator: Brian Lewis, MEDEC Marc-Henri Winter - USFDA Jun Kitahara PMDA Japan Nancy Shadeed Health Canada Cheryl McCrae TGA Australia Fabio Quintino Pereira ANVISA Brazil Gary Minks TÜV SÜD America Inc. Patricia Murphy BSI Healthcare
116 MDSAP: CURRENT STATUS AND FUTURE PLANS CLOSING SESSION: PANEL DISCUSSION Q&A
117 MDSAP: CURRENT STATUS AND FUTURE PLANS Thank you!
Medical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP) Kimberly A. Trautman Executive Vice President, Medical Device International Services Health Sciences Medical Devices NSF International This document is intended
More informationMedical Device Single Audit Program (MDSAP) An Overview Canadian Experience
Medical Device Single Audit Program (MDSAP) An Overview Canadian Experience Linda Chatwin Sr. Customer Solutions Consultant : 360-817-5556 : linda.chatwin@ul.com LINDA M CHATWIN, Esq, RAC Biography Ms.
More informationMedical Device Single Audit Program (MDSAP) Key Points
Medical Device Single Audit Program (MDSAP) Key Points March 2017 Copyright 2016 BSI. All rights reserved. Copyright 2012 BSI. All rights reserved. 1 What is MDSAP? How does MDSAP work? How does MDSAP
More informationMedical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP) October 2017 Roadshow Copyright 2016 BSI. All rights reserved. Copyright 2012 BSI. All rights reserved. 1 How MDSAP works Timelines and Status Auditing Organization
More informationMDSAP Me M dical D e D vice S i S ngle Audit Program
MDSAP Medical Device Single Audit Program Gary Minks VP, Quality & Regulatory Affairs TÜV SÜD America Inc. gminks@tuvam.com Revision: 2013(09(29 TÜV SÜD America 13(04(29 Slide 1 IMDRF International Medical
More information5 Countries. 1 Unified Audit.
5 Countries. 1 Unified Audit. UNDERSTANDING THE MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP) Melodie Kahl, Mike Wolf, and Scott Edwards July 2017 For more information, please contact: USA Office: + 1 877
More informationMDSAP Overview Marseille,
MDSAP Overview Marseille, 20.10.2017 Sigrid Krimmer-Quendler PhD, MSc EMEA Client Manager MDSAP Support Specialist Copyright 2016 BSI. All rights reserved. 1 Who is this woman?!? Sigrid Krimmer-Quendler
More informationMedical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP) Paul Brooks Senior Vice President BSI Healthcare Solutions Copyright 2015 BSI. All rights reserved. 1 Agenda What is MDSAP? How does MDSAP work? I already have
More informationMDSAP AUDIT PROCESS. A Manufacturer s Perspective. Connie Hoy EVP Regulatory Affairs Cynosure, Inc.
MDSAP AUDIT PROCESS A Manufacturer s Perspective Connie Hoy EVP Regulatory Affairs Cynosure, Inc. Cynosure Located in Westford, MA Largest manufacturer of Medical Lasers Second location in Hicksville,
More informationMedical Device Single Audit Program (MDSAP) Copyright 2014 BSI. All rights reserved.
Medical Device Single Audit Program (MDSAP) International Medical Device Regulatory Forum (IMDRF) IMDRF Management Committee (MC) regulators: Australia, Brazil, Canada, China, the European Union, Japan
More informationEU Unannounced Audits (UAV) Experience To Date Medical Device Single Audit Program (MDSAP) Copyright 2015 BSI. All rights reserved.
EU Unannounced Audits (UAV) Experience To Date Medical Device Single Audit Program (MDSAP) Copyright 2015 BSI. All rights reserved. Background & Requirements - See Webinars BSI Website Copyright 2015 BSI.
More informationTrial acceptance of MDSAP audit reports in Japan
Trial acceptance of MDSAP audit reports in Japan Pharmaceuticals and Medical Devices Agency (PMDA), Office of Manufacturing / Quality and Compliance March 2018 1 Japan s participation to MDSAP International
More informationFINAL DOCUMENT. International Medical Device Regulators Forum. Medical Device Regulatory Audit Reports
FINAL DOCUMENT International Medical Device Regulators Forum Title: Authoring Group: Medical Device Regulatory Audit Reports IMDRF MDSAP Working Group Date: 2 October 2015 Toshiyoshi Tominaga, IMDRF Chair
More informationIVD Inspections Technical Update Dr Dragana Milic Medical devices inspections
IVD Inspections Technical Update 2018 Dr Dragana Milic Medical devices inspections 1 Objectives Harmonisation - internal and external (PQ Medicines/Vaccines/Vector Control and MDSAP) Transparency (clarify
More informationISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes. Theresa McCarthy
ISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes Theresa McCarthy Welcome and Introductions Please interview and collect: Name Primary Quality Management
More informationContents. Regulatory Bodies... 13
Contents UNITED STATES... 3 Regulatory Bodies... 3 Product Classification and Regulatory Control... 3 Application Documents... 3 Quality System Requirements... 4 Product and Manufacturer s License... 4
More informationCANADA (HEALTH CANADA)
1 GMP GAZETTE TM January 2016 HPFBI CANADA (HEALTH CANADA) NNHPD NHPs Notice to Stakeholders Regarding Site Licensing Update Who s affected? Manufacturers, packagers, labellers, importers, and distributors
More informationAuditing Within the Culture of the Medical Device Industry & ISO 13485:2016 Overview. ASQ Quality Conference 2017 for Region 5 October 25, 2017
Auditing Within the Culture of the Medical Device Industry & ISO 13485:2016 Overview ASQ Quality Conference 2017 for Region 5 October 25, 2017 Introduction / Purpose Discuss the influences of regulatory
More informationHosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil)
Hosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil) Kathrin Abelein Vice President Quality, R-Pharm, JSC First Russian GMP Conference 20. 22. September 2016 Agenda General information
More informationMedical Device Single Audit Program (MDSAP)
Medical Device Single Audit Program (MDSAP) IMDRF MDSAP International Medical Device Regulators Forum Medical Device Single Audit Program IMDRF recognises that a global approach to auditing and monitoring
More informationEditor : Francoise SCHLEMMER Date : 09/03/2015 IMDRF, March 9 th 2015 REPORT Present : Hans-Heiner Junker Francoise SCHLEMMER
The European Association Medical Devices - Notified Bodies TEAM-NB A.I.S.B.L. Boulevard Frère Orban 35A B 4000 Liège BELGIQUE Tél.: + 32 (0)4 254 55 88 Fax: + 32 (0)4 254 55 89 E-mail: secretary@team-nb.org
More informationMEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND ISO 14155 EXECUTIVE SUMMARY Medical device regulations around the world generally require manufacturers of most types of medical devices to supply data as part
More informationCourse Title ID Duration Basic Premium. Biological Evaluation of Medical Devices: A Risk-Based Approach N mins
Pre-Clinical Basic Level : CMDA Certified Medical Device Associate Biological Evaluation of Medical Devices: A Risk-Based Approach N134 63 mins 186.00 144.00 Introduction to Process Validation N135 75
More informationABRIDGED PREQUALIFICATION ASSESSMENT. Prequalification of In Vitro Diagnostics
P r e q u a l i f i c a t i o n T e a m - D i a g n o s t i c s ABRIDGED PREQUALIFICATION ASSESSMENT Prequalification of In Vitro Diagnostics PQDx_173 v3 12 September 2017 (This document version supersedes
More informationAAMI Quality Systems White Paper
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017, Updated February 2018 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward,
More informationDocument issued on: March 19, The draft of this document was issued on May 20, 2010.
Reprinted from FDA s website by Guidance for Industry, Third Parties and Food and Drug Administration Staff Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program Document issued
More informationExpert Commentary on BS EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes
Expert Commentary on BS EN ISO 13485:2016, Medical devices Quality management systems Requirements for regulatory purposes Author: Eamonn Hoxey, PhD, F.R.Pharm.S., Vice President, Medical Devices Quality
More informationISO Introduction and Background
ISO 13485 Introduction and Background After more than 10 years, the updated Quality Management standard with the revision of ISO 13485 for the medical device industry is here. The origins of ISO 13485
More informationPanel Discussion: European Medical Device Regulations Preparing for the Storm Moderator: Lenita Y. Sims Spears, Senior Quality Consultant/Senior
Panel Discussion: European Medical Device Regulations Preparing for the Storm Moderator: Lenita Y. Sims Spears, Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica Panelists:
More informationMedical Device Product Innovation
Medical Device Product Innovation Madoka Murakami PMDA, Japan AMDC Industry Training, 3-5 Oct 2017, Surabaya Agenda Introduction of PMDA Medical Device TPLC and Quality Management Typical Nonconformities
More informationFinal Document. 18 September 2014
IMDRFIMDSAP WG/N11FINAL:2014 International Medical Device Regulators Forum Final Document Title: MD SAP Assessment and Decision Process for the Recognition of an Auditing Organization Authoring Group:
More informationUNICEF TECHNICAL REQUIREMENTS FOR MEDICAL DEVICES (MD)
UNICEF TECHNICAL REQUIREMENTS FOR MEDICAL DEVICES (MD) A. Background January 2019 UNICEF Technical requirements for Medical Devices are the requirements that suppliers need to comply with, and that products
More informationNOTICE. Re: Guidance Document GD211: Guidance on the Content of Quality Management System audit reports
June 8, 2011 NOTICE Our file number: 11-110913-528 Re: Quality Management System audit reports is pleased to announce the release of the guidance document GD211: Guidance on the Content of. A draft version
More informationDITTA CONTRIBUTION TO IMDRF STAKEHOLDER FORUM
DITTA CONTRIBUTION TO IMDRF STAKEHOLDER FORUM Satoshi Kimura DITTA Chair JIRA Executive Director IMDRF Stakeholder Forum Tokyo, 25 Mar. 2015 Key Topics Updates about DITTA DITTA views on current work items
More informationProgress of QMS/QSD WG
4th Joint Conference of Japan and Taiwan Progress of QMS/QSD WG Katsuya SAWADAISHI Office of Manufacturing/Quality and Compliance Division of Medical Devices December 7th, 2016 Main Topics 1. QSD/QMS WG
More informationWHO Prequalification of In Vitro Diagnostics Programme
P r e q u a l i f i c a t i o n T e a m - D i a g n o s t i c s Information for Manufacturers on the Manufacturing Site(s) Inspection (Assessment of the Quality Management System) WHO Prequalification
More informationJapan Update - Implementation of PMD Act - March, 2015
Japan Update - Implementation of PMD Act - March, 2015 Topics Implementation of PMD Act; Revision of Pharmaceutical Affairs Law (PAL) PMDA Medical Device Training Seminar 2 Implementation of PMD Act: The
More informationPROPOSED DOCUMENT. Global Harmonization Task Force
PROPOSED DOCUMENT Global Harmonization Task Force Title: Quality management system Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange Authoring Group: Study
More informationCOCIR/MITA Joint Contribution. EU and US call for input on regulatory issues for possible future trade agreement
COCIR/MITA Joint Contribution EU and US call for input on regulatory issues for possible future trade agreement COCIR and MITA welcome the opportunity to share ideas with the United States government and
More informationIMDRF. Final Document. Regulatory Authority Assessor Competence and Training Requirements. IMDRF MDSAP Work Group
IMDRF/ WG /N6 FINAL:2013 IMDRF International Medical Device Regulators Forum Final Document Title: Authoring Group: Regulatory Authority Assessor Competence and Training Requirements IMDRF MDSAP Work Group
More informationComplete global Solutions
Complete global Solutions for ELECtro-Medical devices get your product to market faster we know the way 1 sgs medical network THE As a medical devices manufacturer your focus is to create products that
More information2 DAY WORKSHOP on Preparing For The New EU Medical Device Regulations (MDR)
WORLD COMPLIANCE SEMINARS SPEAKER:- DAVID R DILLS Regulatory Affairs & Compliance Consultant 2 DAY WORKSHOP on Preparing For The New EU Medical Device Regulations (MDR) 21-22, FEB- 2018 Burlingame CA Course
More information2 DAY WORKSHOP on Preparing For The New EU Medical Device Regulations (MDR)
WORLD COMPLIANCE SEMINARS SPEAKER:- DAVID R DILLS Regulatory Affairs & Compliance Consultant 2 DAY WORKSHOP on Preparing For The New EU Medical Device Regulations (MDR) 21-22, FEB- 2018 Burlingame CA Course
More informationPrequalification of in vitro diagnostics - Technical Update 24 November 2015
Prequalification of in vitro diagnostics - Technical Update 24 November 2015 Copenhagen, Denmark 22-26 November 2015 1 Product Dossier Copenhagen, Denmark 22-26 November 2015 2 PQDx Data Quality Expectations
More informationELECtro-Medical devices. in trusted hands. sgs is the world s leading
ELECTRICAL & ELECTRONICS electro MEDICAL DEVICES ELECtro-Medical devices in trusted hands sgs is the world s leading testing and certification company 1 sgs medical network: THE As a medical devices manufacturer
More informationASQ Tappan Zee Section Medical Devices, New Regulations and Standards. 26 th September / V. Fischer / Rev. 01
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards 26 th September / V. Fischer / Rev. 01 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINE FOR A LICENCE TO MANUFACTURE, IMPORT, EXPORT OR DISTRIBUTE MEDICAL DEVICES & IVDs This guideline is intended to provide recommendations to applicants wishing to submit
More informationTrinity College Dublin QP Forum 2017 Tuesday 25 th April
Trinity College Dublin QP Forum 2017 Tuesday 25 th April HPRA QUESTIONS & ANSWERS 1. What is the approach being taken for audit of contamination control strategies as per chapters 3 & 5? What is the current
More informationWHO Prequalification of In Vitro Diagnostics
WHO Prequalification of In Vitro Diagnostics 3 rd WHO Global Forum on Medical Devices Geneva, 10 May 2017 Helena Ardura & Deirdre Healy WHO PQ Team Diagnostics Assessment Essential Medicines and Health
More informationCBI s 15 th Annual Product Complaints Congress for Life Sciences
CBI s 15 th Annual Product Complaints Congress for Life Sciences June 14, 2017 Steven Niedelman Lead Quality Systems & Compliance Consultant King & Spalding LLP 1700 Pennsylvania Ave., NW Washington, DC
More informationUpdate on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations
Update on Regulatory Environment- Europe Experience with 2007/47/EC M5 & Discussions on Possible Recast of EU Medical Device Regulations Paul Brooks Vice President Healthcare, Americas Presentation to:
More informationExcipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification
Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification European Compliance Academy Vienna, 20 th & 21 st October 2009 Dr Iain Moore Chair Certification Committee
More informationSUMMARY REPORT OF THE SG1 MEETING HELD ON 18/19 th FEBRUARY 2004 IN CANBERRA
SUMMARY REPORT OF THE SG1 MEETING HELD ON 18/19 th FEBRUARY 2004 IN CANBERRA Attendees Europe Maurice Freeman - Chairman Alan Kent Secretary Elke Lehmann BfArM, Germany Benny Ons EDMA/EMIG Petra Kaars-Wiele
More informationThe Third Annual BSI Medical Device Regulatory Road Shows
The Third Annual BSI Medical Device Regulatory Road Shows September 2014 Monday, September 8, 2014 Santa Clara Biltmore Friday, September 12, 2014 Boston Marriott Burlington Wednesday, September 10, 2014
More informationQuality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Today, many companies operate
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 5 GLP Auditing 6 Pharmacovigilance Auditing 6 Vendor/Supplier Auditing 7
More information1. GMP/Quality issues Report back from the discussion in last year s symposium
2 nd Japan - India Medical Products Regulation Symposium 1. GMP/Quality issues Report back from the discussion in last year s symposium Mr. Fumihito Takanashi, Office of International Regulatory Affairs
More informationDiagnostics new product development: overview, WHO s scientific and regulatory role, regulatory pathways and demand creation
Diagnostics new product development: overview, WHO s scientific and regulatory role, regulatory pathways and demand creation Irena Prat Technical Officer, PQDx 1 Global Dx regulatory landscape Dx regulation
More informationAAMI Quality Systems White Paper: Comparison of 21 CFR Part 820 to ISO 13485:2016 1
AAMI s White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 February 2017 AUTHORS Seb Clerkin, GMP Advisory Services Nicola Martin, Owner, Nicola Martin Consulting Jack Ward, Owner, Ward Sciences
More informationDITTA STANDARDS. What makes a standards a great standard. Industry View. September 2017 Ottawa, Canada
DITTA STANDARDS What makes a standards a great standard Industry View September 2017 Ottawa, Canada Elisabeth George Philips Head of Global Regulations & Standards MEDICAL DEVICE INDUSTRY PERSPECTIVE Introduction
More informationDrug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel
Drug Quality Assurance: Systems at ChemCon Author: Dr. Peter Gockel On February 13th, 2006, the FOOD AND DRUG ADMINISTRATION (FDA) implemented a revision to the Compliance Program Guidance Manual for active
More informationHow to Get ISO Certified
People frequently ask me where to locate information about ISO 13485, so this whitepaper was written specifically to address their needs, as well as review in detail the six steps to preparing for ISO
More informationGlobal Development of Drugs and Co-operation among Asian Economies
Global Development of Drugs and Co-operation among Asian Economies Chi-Chou Liao, Ph.D. Director General Bureau of Pharmaceutical Affairs, Department of Health, Chinese Taipei 2006 Symposium on Asia Pacific
More informationDavid W Feigal, Jr., MD MPH
Global Harmonization Summit Where have we been with Harmonization? David W Feigal, Jr., MD MPH Adjunct Professor, College of Law, Arizona State University Partner, NDA Partners LLP September 18, 2014 Washington
More informationGxP Auditing, Remediation, and Staff Augmentation
GxP Auditing, Remediation, and Staff Augmentation TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing 8
More informationSafety and Performance Grading of Quality Management System Nonconformities
Safety and Performance Grading of Quality Management System Nonconformities CAPT Kimberly Lewandowski-Walker FDA/ORA/Office of Medical Products and Tobacco Operations National Expert, Medical Devices Goal
More informationexcipients Setting the Scene
NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Multiple stakeholders; one objective. Presented by Janeen Skutnik-Wilkinson International Pharmaceutical Excipients Council
More informationISO 13485:2016. What s in it - and what does it mean?
ISO 13485:2016 What s in it - and what does it mean? QAdvis key competence areas Turn key quality systems Sharepoint based Digital signatures Efficient and lean Validated and compliant QMS in-the cloud
More informationGxP Auditing, Remediation, and Quality System Resourcing
GxP Auditing, Remediation, and Quality System Resourcing TABLE OF CONTENTS 3 Introduction 4 GxP Auditing 4 GMP Auditing 5 GCP Auditing 6 GLP Auditing 7 Pharmacovigilance Auditing 7 Vendor/Supplier Auditing
More informationPrevent Quality System Deficiencies by Conducting Effective Internal Audits. Whitepaper
Prevent Quality System Deficiencies by Conducting Effective Internal Audits Whitepaper An internal audit system is one of the most effective ways to monitor, analyze, control, and improve quality management
More informationIntroduction and Case Sharing of FDA CGMP Inspections
Presentation title Date Introduction and Case Sharing of FDA CGMP Inspections Second Russian GMP Conference 2017 Andrew Chang, Ph.D Vice President, Quality and Regulatory Compliance Novo Nordisk A/S Presentation
More informationOptimising the management of post-approval changes for patients timely access to medicines
Optimising the management of post-approval changes for patients timely access to medicines The industry perspectives with a Pledge for Convergence 7th APAC, April 2018 Sannie Chong (Ph.D. FRSC) Asia Pacific
More informationMedtech: Global Regulatory Strategy in Medical Device Product Development
Medtech: Global Regulatory Strategy in Medical Device Product Development We contribute to healthcare For Medical Device & Drug May Ng Director, Regulatory & Quality Consultant may.ng@arq-on.com Disclaimer:
More informationAS9101 Revision E Understanding the Changes
AS9101 Revision E Understanding the Changes Introduction Aviation, space and defense (ASD) organizations are highly regulated to ensure their products are safe and reliable, conform to statutory and regulatory
More informationProcess validation in medical devices
Process validation in medical devices Fulfil requirements with expert regulatory guidance 1TÜV SÜD Contents INTRODUCTION 4 VALIDATION PLANNING 5 INSTALLATION QUALIFICATION 7 OPERATIONAL QUALIFICATION 9
More informationProcess validation in medical devices
Process validation in medical devices Fulfil requirements with expert regulatory guidance 1TÜV SÜD Contents INTRODUCTION 4 VALIDATION PLANNING 5 INSTALLATION QUALIFICATION 7 OPERATIONAL QUALIFICATION 9
More informationLIFE SCIENCE BENCHMARKING STUDY. Trends and Best Practices Based on Our Work with the US FDA and Over 250 Companies
LIFE SCIENCE 01 BENCHMARKING STUDY Trends and Best Practices Based on Our Work with the US FDA and Over 0 Companies SUMMARY In this report, UL EduNeering has identified the 01/01 compliance and business
More informationISO13485: An Overview - Gunter Frey Member, SG3 NEMA
ISO13485:2003 - An Overview - Member, SG3 NEMA Americas (FDA/CMDR) Regulatory Authorities Europe (Competent Authorities) A Global View India (AERB) Singapore (HSA) Thai FDA Malaysian Govt Russia (GHOST)
More informationExcipient GMP GDP Certification Project. Presentation to FECC Seminar Brussels 19 th March 2009 Dr Iain Moore Chair GMP Committee IPEC Europe
Excipient GMP GDP Certification Project Presentation to FECC Seminar Brussels 19 th March 2009 Dr Iain Moore Chair GMP Committee IPEC Europe Excipient GMP GDP and Certification 1. Basis for Project 2.
More informationQMS Aspects of the MDR (& IVDR)
QMS Aspects of the MDR (& IVDR) Vicky Medley Global QMS Manager Medical Devices 27 February 2018 Copyright 2018 BSI. All rights reserved This Presentation 1. The clock is ticking! 2. Dates & priorities
More informationImplementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan
JCCT workshop on Q8/Q9/Q10 Beijing Implementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan Yukio HIYAMA Chief, 3 rd Section, Division of Drugs National Institute of Health Sciences, Ministry
More informationStaffing - Medical Devices
Staffing - Medical Devices LONDON GENEVA SINGAPORE DUBLIN procorre.com 1 Implementing solutions to clients worldwide 2 Contents Services 04 Sector Overview 07 Medical Devices 07 In-Vitro Diagnostics 08
More informationRegulatory Framework in Japan - Past and Future - Building a Regulatory Framework Essential Elements of Compliance / Surveillance
Regulatory Framework in Japan - Past and Future - Building a Regulatory Framework Essential Elements of Compliance / Surveillance Nobuo UEMURA Director Office of Medical Devices III Pharmaceuticals and
More informationAn overview of international initiatives in the regulatory sphere
The place of the Certification Procedure in the global regulatory environment 19/20 September 2017, Prague, Czech Republic An overview of international initiatives in the regulatory sphere Cordula Landgraf
More informationEffective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The globalization of the pharmaceutical
More informationUpdate on the International Medical Device Regulators Forum
Update on the International Medical Device Regulators Forum Melissa Torres, ME, MS Associate Director for International Affairs Office of the Center Director Center for Devices and Radiological Health
More informationShift from Approved Vendor to Strong Supply Chain Partner
Shift from Approved Vendor to Strong Supply Chain Partner Presented by Randall D Amico November 10, 2015 11/11/2015 Slide 1 Our heritage: 149 years of business success 1866 1906 Establishment of a Mannheim-based
More information1. PMDA Chief Executive Dr. Kondo s New Year message for 2015
PMDA Updates January, 2015 Camellia japonica News 1. PMDA Chief Executive Dr. Kondo s New Year message for 2015 A Happy New Year to all of you. PMDA has been promoting regulatory science through the operation
More informationto protect human health throughout the life-cycle of medicinal products;
ICMRA Communications Strategy: 2018-2020 Introduction The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, highlevel, strategic coordinating, advocacy and leadership
More informationISO FDA QSR. ISO and FDA QSR: A Step by Step Guide to Complying with Medical Device QMS Requirements
ISO 13485 FDA QSR ISO 13485 and FDA QSR: A Step by Step Guide to Complying with Medical Device QMS Requirements Jon Speer Founder & VP of QA/RA greenlight.guru Table of Contents 1 Introduction 4 QMS Philosophy
More informationSelf-Inspection and its potential benefits via ICH Q9 & Q10
Self-Inspection and its potential benefits via ICH Q9 & Q10 Kevin O Donnell, Ph.D. Senior Inspector & Market Compliance Manager Irish Medicines Board IMB Information Day October 23 rd, 2008 Slide 1 Topics
More informationU.S. FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH UPDATE. Jeff Shuren Director Center for Devices and Radiological Health
U.S. FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH UPDATE Jeff Shuren Director Center for Devices and Radiological Health 21 ST CENTURY CURES ACT IMPLEMENTATION Provision Implementation activities completed
More informationConduct a More Effective Management Review. Rob Packard, Consultant
Conduct a More Effective Management Review & Slide 1 of 31 Your Speaker Rob Packard Rob Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology
More informationEU MDR 10 Things Packaging Engineers Should Know
EU MDR 10 Things Packaging Engineers Should Know networkpartners.com NUMBER ONE THE TIME FOR ACTION IS NOW First, some background: The EU Medical Device Regulation (MDR) was approved by the European Parliament
More informationMedical Device Communiqué
Medical Device Communiqué Q2 2013 Demonstrating the Safety of Medical Devices in the Human Body 1 DOJ: The Focus is on GMPs in 2013 2 ROHS II Impacts Medical Device Companies 3 Demonstrating the Safety
More informationCOMBINATION PRODUCTS Inspection Readiness and Outcomes
WHITE PAPER COMBINATION PRODUCTS Inspection Readiness and Outcomes Many companies think that because they have a good relationship with the FDA Center they interacted with during their submission reviews
More informationQMS regulation in Japan. Office of Manufacturing/Quality and Compliance As of 1st April, 2015
QMS regulation in Japan Office of Manufacturing/Quality and Compliance As of 1st April, 2015 Manufacturing/Quality and Compliance Manufacturing/Quality and Compliance QA of GMP/QMS GMP QMS KANSAI Branch
More informationQuality Manual. Print Name Title Date Prepared by L Naughton QA Consultant 9 th April 09. Reviewed by Bernard Lennon Fire and Safety Officer
Quality Manual Print Name Title Date Prepared by L Naughton QA Consultant 9 th April 09 Reviewed by Bernard Lennon Fire and Safety Officer 9 th April 09 Corporate Authorisation Joe Hoare Estates Officer
More informationGlobal Medical Device QA/RA Consulting
EmergoGroup.com Global Medical Device QA/RA Consulting More than 2,800 companies trust Emergo to achieve and maintain compliance with global medical device and IVD regulations. Core Areas of Expertise
More information