Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (COM) COURSE DESCRIPTION
|
|
- Robert McAllister
- 5 years ago
- Views:
Transcription
1 Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (COM) COURSE DESCRIPTION The globalization of the pharmaceutical supply chain has led increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particularly since the operations are not in your facility and therefore not under your direct control. The compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious compliance and data integrity issues at foreign CMO sites. If you use CMOs, your company has the ultimate responsibility for product quality, safety, efficacy, and cgmp compliance. Furthermore, FDA has clearly stated that organizations using CMOs will be held accountable for CMO compliance to cgmps, as well as adherence to regulatory commitments. Therefore, issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your company. Since FDA is holding firms using CMOs responsible, it is imperative that your organization have a robust CMO management system. At the end of the day, your organization s ability to provide proper quality oversight of CMOs is the key to assuring product safety and your company s compliance profile. This seminar will help all personnel responsible for CMO oversight understand how to manage CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, Quality Agreements, Understanding of CMO Operations, and Review of Key CMO Records. Considerations for different types of manufacturing will be highlighted, and techniques for managing difficult CMO situations will be discussed. This is a practical how-to course, designed to provide participants with skills they can immediately apply to CMO oversight within their own organizations. Group exercises will allow participants to practice skill sets with feedback from the instructor. Learning Objectives: Upon completing this course, participants should be able to: Understand the CMO business model Learn the regulatory requirements for CMO quality oversight Learn how to structure your organization for effective CMO oversight Learn key points for selecting and qualifying CMOs Learn how to prepare for and conduct CMO Qualification Audits Learn how to develop a Quality Agreement and how to execute it Learn how to understand CMO operations Learn key points for reviewing CMO records Learn how to resolve issues identified in CMO records Learn how to prepare for and conduct routine CMO audits Learn how to manage CMOs on an ongoing basis Who will Benefit: This course is designed for people tasked with oversight of these CMO functions: Manufacturing operations Quality Control operations Quality Assurance operations The following personnel will benefit from the course: Pharmaceutical Development
2 Quality Control Validation Regulatory Affairs Quality Assurance Project Management AGENDA Day 01(8:00 AM - 4:30 PM) Registration Process: 8:30 AM 9:00 AM Session Start Time: 9:00 AM The CMO Business Model What is CMO Oversight? Regulatory Requirements for CMO Oversight FDA Expectations and Warning Letters Structuring Your Organization for CMO Oversight Manufacturing Chemistry / Laboratory Quality Assurance Regulatory Affairs Project Management Group Exercise # 1- Structuring Your Organization CMO Selection and Qualification Key Selection / Qualification Criteria Overall Considerations Considerations for API CMOs Considerations for Drug Product CMOs Considerations for Aseptic Manufacturing CMOs Considerations for Testing Laboratory CMOs Evaluating CMOs vs. Selection / Qualification Criteria Group Exercise # 2- CMO Selection and Qualification CMO Qualification Audits Overall Considerations for CMO Qualification Audits CMO Questionnaires Risk Assessments for Use of Questionnaires Evaluation of Questionnaire Responses Audit Planning Auditor Selection Determining Audit Purpose / Scope Audit Agenda Audit Execution Introductory Meeting / Orientation Area Tours Document Review / Interviews Time Management Audit Findings Group Exercise # 3- Audit Agenda The Quality Agreement Regulatory Requirements Elements of the Quality Agreement Negotiating the Quality Agreement
3 Executing the Quality Agreement Group Exercise # 4- Quality Agreement Day 02(8:00 AM - 4:30 PM) Getting to Know Your CMO Understanding CMO Operations Operational/Communication Style How to Deal with the Seven CMO Personality Types Review of Key CMO Records Batch Records Change Controls Group Exercise # 5- Change Control Critique Deviation Investigations / CAPA Group Exercise # 6- Deviation Investigation Critique OOS Investigations Group Exercise # 7- OOS Investigation Critique Hot Topic- Data Integrity Routine CMO Audits Audit Planning Audit Execution Differences from CMO Qualification Audits Ongoing CMO Oversight Overall Considerations Elements of Effective Ongoing CMO Oversight SPEAKER Andrew Campbell Pharmaceutical Consultant - Quality & Compliance Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management. Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems. PARTNERS/SPONSORS We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before,
4 during and after the event. Benefits of becoming a Sponsor/Exhibitor/Media Partner: Logo on website, marketing , branding materials & the registration booth Logo on website, marketing , branding materials & the registration booth Exhibit Space Free event pass Speaking opportunity Social media campaign Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for: - Multiple participant discounts - Price quotations or visa invitation letters - Payment by alternate channels (PayPal, check, Western Union, wire transfers etc) - Event sponsorships NO REFUNDS/TRANSFERS ALLOWED ON REGISTRATIONS Prices may go up any time. Service fees included in pricing This event is brought to you by: ComplianceOnline.com - NewYorkEventsList JOA190513CEV
Effective 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 informationSOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized
More informationPV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires
More informationPulmonary We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct co
Pulmonary We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct coding, reimbursement and compliance Learn Pulmonary
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 informationGastroenterology We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist cor
Gastroenterology We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct coding, reimbursement and compliance Learn Gastroenterology
More informationSOPs for FDA-Regulated Industry Best Practices to Withstand FDA Expectations
SOPs for FDA-Regulated Industry Best Practices to Withstand FDA Expectations *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! One of the best ways to ensure that an organization
More informationMost Cardiology seminars are sponsored by the State Chapters of the ACC.
Cardiology We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct coding, reimbursement and compliance Learn Cardiology
More informationMost Cardiology seminars are sponsored by the State Chapters of the ACC.
Cardiology We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct coding, reimbursement and compliance Learn Cardiology
More informationMost Cardiology seminars are sponsored by the State Chapters of the ACC.
Cardiology We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct coding, reimbursement and compliance Learn Cardiology
More informationValidation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!
More informationInvestigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings Submissions to a regulatory agency involve more than just writing
More informationEffectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This seminar
More informationSciences, South Carolina College of Pharmacy, MUSC Campus, Charleston, SC.
Live Las Vegas CME Day 1 Schedule New Drug Update Part 1 5 hours Wednesday, 6/12/2019 Check-in and Breakfast: 7:30AM 8:00AM Educational Session: 8:00AM 1:30PM At the completion of this activity, the participant
More informationMaintenance Reserves Seminar 2019
Maintenance Reserves Seminar 2019 This event will cover in-depth all aspects of maintenance reserves, what you need to know and how to put it into practice. It will discuss typical issues pertaining to
More informationMost Peripheral Cardiology seminars are sponsored by the State Chapters of the ACC.
Peripheral Cardiology We provide answers: The most current ICD-10 and CPT coding instruction ICD-10-CM examples for your specialty Strategies to assist correct coding, reimbursement and compliance What
More information21 CFR Part 11 Compliance for SaaS/Cloud Applications
21 CFR Part 11 Compliance for SaaS/Cloud Applications *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This highly interactive two-day course uses real life examples and explores
More informationTechnical Aspects of a Leased Asset 2019
Technical Aspects of a Leased Asset 2019 This one day seminar will discuss the growing role of aircraft and engine leasing to worldwide airline s fleets with an in-depth look at the maintenance issues
More informationComputer System Validation - Reduce Costs and Avoid 483s
Computer System Validation - Reduce Costs and Avoid 483s *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This Computer System Validation Training course will explore proven techniques
More informationReduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This highly interactive two-day course uses
More informationPackaging and Labeling in Pharmaceutical Production
Packaging and Labeling in Pharmaceutical Production *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Seminar to help you understand compliant packaging and labeling process in the
More informationPharmaceutical Good Manufacturing Practice. Contents are subject to change. For the latest updates visit
Pharmaceutical Good Manufacturing Practice Page 1 of 6 Why Attend A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing
More informationPV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The European Medicines Agency's
More informationInvestigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER
More informationApplying ISO14971 / IEC62304 / IEC A Practical Guide On How To Implement Risk Management
Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Risk management is a mandatory
More informationSubpart B Organization and Personnel, 21 CFR Responsibilities of the quality control unit.
FDA inspections continue to focus on CGMP violations related to basic GMP controls. A survey of Warning Letters issued in 2013 on CMC (Chemistry / Manufacturing / Controls) violations reveals an emphasis
More informationDesigning and Sustaining New and Existing Product Stability Testing Program
Designing and Sustaining New and Existing Product Stability Testing Program *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! New or existing modified drug Stability Testing Program's
More informationParticipants of this seminar who pass the optional exam will be eligible for IRF's New Procurement & Contract Professional (Details Coming Soon!
Procurement & Contract Management in Highway Projects Overview This seminar is designed to meet the educational needs of government officials in charge of surface transportation procurements and contracts.
More informationManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER
More information1st IRF Regional Conference & Exhibition for Road Safety The Road to Zero
1st IRF Regional Conference & Exhibition for Road Safety The Road to Zero While efforts to improve road safety in Asia are finally starting to make headway, the challenge to reduce fatalities remains immense.
More informationFDA's New Import Program for Strict Precision
FDA's New Import Program for 2019 - Strict Precision *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The FDA continues to change its import program to better manage new problems
More informationStatistical Analysis for Process and Product Development
Statistical Analysis for Process and Product Development *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This course is designed to help scientists and engineers apply statistical
More informationManaging Your FDA Inspection: Before, During and After
Managing Your FDA Inspection: Before, During and After *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! FDA inspects many different kinds of firms. If the FDA regulates your product,
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 informationIRF Global R2T Conference & Exhibition. Building the Transport Infrastructure of Tomorrow
IRF Global R2T Conference & Exhibition Building the Transport Infrastructure of Tomorrow Automated, Connected, Safe & Intelligent The IRF Global R2T Conference & Exhibition is the new international meeting
More informationBiocompatibility Testing for Medical Devices
Biocompatibility Testing for Medical Devices *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The medical device field is one of the most heavily regulated industries, for obvious
More informationBiocompatibility Testing for Medical Devices
Biocompatibility Testing for Medical Devices *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The medical device field is one of the most heavily regulated industries, for obvious
More informationThe FDA Just Arrived... Are You Ready? Presented By Sandra Lueken Sr. Director, Quality AstraZeneca Biologics
The FDA Just Arrived... Are You Ready? Presented By Sandra Lueken Sr. Director, Quality AstraZeneca Biologics Objectives Review Quality Systems Audit Approach and cgmp fundamentals Logistical Audit Preparation
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 informationRisk Based Incoming Quality Assurance (IQA)
Microrite, Inc. brings you this unique learning experience in Risk Based Incoming Quality Assurance (IQA); Part of Microrite s step-by-step webinar series. Risk Based Incoming Quality Assurance (IQA) In
More informationSurvival Kit for Regulatory Inspections
Creators of the GMP Ready-to-Use Training System Having the FDA or other regulatory agency arrive to conduct an inspection can be stressful, even terrifying! Being caught off-guard can lead to severe consequences.
More informationTennessee: Leader As Coach: Leadership Development Master Class (BLR)
Tennessee: Leader As Coach: Leadership Development Master Class (BLR) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Wednesday, May 15, 2019 Las Vegas, NV Increasingly organizations
More informationAgenda: Day 1 Schedule 8:30 AM - 9:00 AM: Registration
FDA Scrutiny of Promotion and Advertising Practices Overview: If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for
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 informationPAI Inspections, Observations and Data Integrity
PAI Inspections, Observations and Data Integrity Krishna Ghosh, Ph.D. Office of Pharmaceutical Quality Office of Process and Facilities Center for Drug Evaluation and Research November, 2017 20 November
More informationStability Studies for Pharmaceutical Products (API and finished products)
A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry Stability Studies for Pharmaceutical Products (API and finished products)
More informationEvaluation and Management Boot Camp Professional Version
Evaluation and Management Boot Camp Professional Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview Become a pro at assigning, verifying, and auditing E/M codes.
More informationLive Florida CME Live Florida CE & CME in Bonita Springs for 15 Contact Hours
Live Florida CME Live Florida CE & CME in Bonita Springs for 15 Contact Hours Live Florida CE & CME! Join us on the Gulf Coast January 23-25, 2020, hosted at the luxurious Hyatt Regency Coconut Point Resort
More informationEnsuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Federal regulation of the advertising
More informationProcess Validation for FDA Regulated Industries
Microrite, Inc. brings you this unique learning experience in Process Validation for FDA Regulated Industries; Part of Microrite s step-by-step webinar series. Process Validation for FDA Regulated Industries
More information2019 Revenue Integrity Symposium
2019 Revenue Integrity Symposium *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Coming October 15 16, 2019 Renaissance Orlando - Orlando, FL Save the Date: Join us October 15 16,
More informationFocused Trends from the FDA
Focused Trends from the FDA GXP INSPECTION READINESS Jolly Bhatia Sr. Director, QA Alnylam September 21, 2017 Credits: Tim Maines, Arya Tavana, John French, Roan Martin 13% of FDA Complete Response Letters
More informationRoot Cause Analysis and CAPA using 8-D Problem Solving Method
Root Cause Analysis and CAPA using 8-D Problem Solving Method *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Errors and defects are a problem in virtually every industry. The goal
More informationQuality Risk Management (ICH Q9): WHO Model for Sustainable Quality Medicines
Quality Risk Management (ICH Q9): WHO Model for Sustainable Quality Medicines Longe Sunday Anthony Head- Quality Assurance May & Baker Nigeria Plc. Pharmacentre, Ota, Nigeria eaglesconsult@gmail.com; Slonge@may-
More information2nd Annual Mining Investment North America
2nd Annual Mining Investment North America THE FOREMOST NORTH AMERICAN FORUM FOR THE GLOBAL MINING COMMUNITY Mining Investment North America is a strategic mining conference and exhibition for the leaders
More informationCertified Chief Information Security Officer (CCISO)
Certified Chief Information Security Officer (CCISO) The CCISO program trains individuals who are looking to make the jump from middle management to the executive ranks by focusing on high-level management
More informationThis live CE / CME experience is accredited for MDs, PAs, Pharms, Pharm Techs, NPs and Nurses!
Live Las Vegas CME Join us for a Live CME Conference in Las Vegas + 15 Contact Hours Join us in Las Vegas for a live CME conference and vibrant nightlife, shows and fine dining. This conference, Current
More informationMedicare Boot Camp Provider-Based Departments Version
Medicare Boot Camp Provider-Based Departments Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview Reimbursement for provider-based departments (PBD) and clinics
More informationMedicare Boot Camp Rural Health Clinic Version
Medicare Boot Camp Rural Health Clinic Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview Medicare Boot Camp Rural Health Clinic Version is a one-day intensive
More informationMedicare Boot Camp Rural Health Clinic Version
Medicare Boot Camp Rural Health Clinic Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview Medicare Boot Camp Rural Health Clinic Version is a one-day intensive
More informationMedicare Boot Camp Rural Health Clinic Version
Medicare Boot Camp Rural Health Clinic Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview Medicare Boot Camp Rural Health Clinic Version is a one-day intensive
More information2ND ANNUAL INVESTMENT EUROPE
2ND ANNUAL INVESTMENT EUROPE THE PREFERRED MINING INVESTMENT FORUM IN CONTINENTAL EUROPE Mining Investment Europe is a strategic mining conference and exhibition for the leaders of the mining, quarrying
More informationStatistical Process and Quality Control
Statistical Process and Quality Control *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This 2-day seminar includes the steps and techniques used to quantify variability in manufacturing
More informationInternational Trade Finance
International Trade Finance *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This is an intensive 2-day primer for banking & financial professionals on International Trade Finance.
More information3rd Annual Mining Investment India
3rd Annual Mining Investment India THE FOREMOST SOUTH ASIAN FORUM FOR THE GLOBAL MINING COMMUNITY Mining Investment India is a strategic mining conference and exhibition for the leaders of the mining,
More informationCompanies are realizing the value of. cost-effective option. an opinion regarding a business company performance.
WORLD COMPLIANCE SEMINARS SPEAKER:- CHINMOY ROY BSEE, MSCS US FDA EXPERT DATA INTEGRITY & CSV. 1 Seminars 2 Onsite Training 3 Consulting 1 Consulting is providing expert We provide onsite Business Seminars
More informationResidency Program Coordinator Boot Camp
Residency Program Coordinator Boot Camp *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview HCPro's Residency Program Coordinator Boot Camp is an intensive two-day course
More informationInternational Trade Finance
International Trade Finance *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! This is an intensive 2-day primer for banking & financial professionals on International Trade Finance.
More informationSafety Culture 2019 (BLR)
Safety Culture 2019 (BLR) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Denver, CO- September 18-20, 2019 CONFERENCE SNAPSHOT: Safety Culture 2019 will empower employers to create
More informationGuidance for Industry Process Validation: General Principles and Practices; A Contract Manufacturing Organization's Approach
May -3, 202 Javits Center New York, NY Guidance for Industry Process Validation: General Principles and Practices; A Contract Manufacturing Organization's Approach Sandra Lueken Director of Quality Baxter
More information2 Day Seminar. Supplier Management for Medical Device Manufacturers 12 RAPS CREDITS. Jun Boston
2 Day Seminar Supplier Management for Medical Device Manufacturers 12 RAPS CREDITS Jun 01 02 Boston Seminar One Registration $ 993 Special Group Discount Register for Four attendees $ 3495 COURSE SUMMARY
More informationNational Conference on Student Leadership
National Conference on Student Leadership The National Conference on Student Leadership (NCSL) is the only student leadership conference that s national in scope, drawing attendees from colleges and universities
More informationHealth Authority Inspection Management. GMP Inspection practices L. Mansolelli, Group Compliance & Auditing June 2012
Health Authority Inspection Management GMP Inspection practices L. Mansolelli, Group Compliance & Auditing June 2012 Abstract As global health authorities align in inspection standards and practices, key
More informationISPE NORDIC COP CLEAN UTILITIES SEPTEMBER TUUSULA FINLAND. Timo Kuosmanen STERIS Finn-Aqua
ISPE NORDIC COP CLEAN UTILITIES SEPTEMBER 7 2016 TUUSULA FINLAND Timo Kuosmanen STERIS Finn-Aqua Timo_Kuosmanen@steris.com AUDIT TRAIL IN CRITICAL UTILITIES MONITORING CURRENT TRENDS CONTENTS BACKGROUND
More informationMedicare Boot Camp Long-Term Care Version
Medicare Boot Camp Long-Term Care Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview HCPro's Medicare Boot Camp Long-Term Care Version covers the latest Medicare
More informationMedicare Boot Camp Long-Term Care Version
Medicare Boot Camp Long-Term Care Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview HCPro's Medicare Boot Camp Long-Term Care Version covers the latest Medicare
More informationMedicare Boot Camp Long-Term Care Version
Medicare Boot Camp Long-Term Care Version *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Course Overview HCPro's Medicare Boot Camp Long-Term Care Version covers the latest Medicare
More informationHR World 2019 *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY!
HR World 2019 *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Three Conferences. One Venue. Unlimited Learning. November 14-15, 2019 Nashville, TN We know you wear many hats at
More informationUnderstanding GxP (GMP, GCP & GLP) for FDA Regulated Industries
Microrite, Inc. brings you this unique learning experience in Understanding GxP (GMP, GCP & GLP) for FDA Regulated Industries; Part of Microrite s step-by-step webinar series. Understanding GxP (GMP, GCP
More informationJoin us at an invaluable platform to seek new partnerships, new business and new opportunities.
3rd Annual Mining Investment London THE FOREMOST GLOBAL MINING FORUM IN THE UNITED KINGDOM Mining Investment London is a strategic mining conference and exhibition for the leaders of the mining, quarrying
More informationAn Introduction to Double Dragon Consulting
An Introduction to Double Dragon Consulting www.doubledragonconsulting.com About DDC Our Experience: - All dosage forms, aseptic processes, API manufacture, OTC - Remediation of 483 observations, Warning
More informationPreventing, Detecting, and Responding to Data Integrity Events. Background, Recent Findings, and Agency Expectations
Preventing, Detecting, and Responding to Data Integrity Events Background, Recent Findings, and Agency Expectations Paula Katz Office of Manufacturing Quality Director, Guidance and Policy Staff FDA/PQRI
More informationBring this workshop to your location: For more information, contact PharmaEd Resources at (217) PharmaED
PharmaED s Register by December 1 st and receive a $300 Discount! O UTSOURCING Qualifying, Working, and Maintaining your Supplier/Vendor Relationship JANUARY 25-26, 2010, RADISSON-PLAZA WARWICK, PHILADELPHIA,
More informationFCTA th International Conference on Fuzzy Computation Theory and Applications
FCTA 2019-11th International Conference on Fuzzy Computation Theory and Applications Fuzzy computation is a field that encompasses the theory and application of fuzzy sets and fuzzy logic to the solution
More informationICISSP 2020, 6th Int. Conf. on Information Systems Security and Privacy
ICISSP 2020, 6th Int. Conf. on Information Systems Security and Privacy SCOPE The International Conference on Information Systems Security and Privacy aims at creating a meeting point for researchers and
More informationInspection Trends. American Society for Quality Richmond, VA Section March 8, 2016
Inspection Trends American Society for Quality Richmond, VA Section March 8, 2016 Brooke K. Higgins, Senior Policy Advisor CDER / Office of Compliance Office of Manufacturing Quality Division of Drug Quality
More information2 Day Seminar Assuring Data Integrity in the Life Science industry. Manufacturers
2 Day Seminar Assuring Data Integrity in the Life Science industry Manufacturers 12 RAPS CREDITS Location 1: Apr 06 07 Boston Location 2: Apr 20 21 San Francisco, CA Seminar One Registration $ 1195 06-Apr,
More informationShanghai Event Program Change Table Sessions Creative Spark
Shanghai Event Program TOPHOTELWORLDTOUR is an exclusive one-day networking conference for leaders of the hospitality industry. Our innovative activities and schedules are geared towards catalysing quality
More informationBarcelona Event Program Change Table Sessions Creative Spark
Barcelona Event Program TOPHOTELWORLDTOUR is an exclusive one-day networking conference for leaders of the hospitality industry. Our innovative activities and schedules are geared towards catalysing quality
More informationKDIR th International Conference on Knowledge Discovery and Information Retrieval
KDIR 2019-11th International Conference on Knowledge Discovery and Information Retrieval Knowledge Discovery is an interdisciplinary area focusing upon methodologies for identifying valid, novel, potentially
More informationHow Pharma Should Monitor itself for GMP Compliance & How FDA Inspections Could Incorporate Pharmaceutical Inspection Cooperation Scheme (PIC/S)
How Pharma Should Monitor itself for GMP Compliance & How FDA Inspections Could Incorporate Pharmaceutical Inspection Cooperation Scheme (PIC/S) ASQ Northeast Pharmaceutical GMP/Quality Conference January
More informationA NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program
A NUSAGE-PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry STERILIZATION TECHNIQUES: STEAM & ETHYLENE OXIDE Instructor Dennis
More informationColorado: Leader As Coach: Leadership Development Master Class
Colorado: Leader As Coach: Leadership Development Master Class *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Wednesday, September 18, 2019 Denver, CO Increasingly organizations
More informationProcess Validation. Instructor Philip K. Ngai, Ph.D.* Senior Advisor & Trainer. National University of Singapore Academy of GxP Excellence (NUSAGE)
National University of Singapore Academy of GxP Excellence (NUSAGE) & PharmEng Technology Presents Part of the Pharmaceutical and Biotechnology Training Courses Instructor Philip K. Ngai, Ph.D.* Senior
More informationNUSAGE PharmEng. Pharmaceutical and Biotechnology Training Program COMPUTERIZED SYSTEM VALIDATION
COMPUTERIZED SYSTEM VALIDATION NUSAGE PharmEng Pharmaceutical and Biotechnology Training Program Shaping Human Capital for Challenges in the Pharmaceutical Industry Objective COMPUTERIZED SYSTEM VALIDATION
More informationFOREIGN DRUG INSPECTION/AUDITS FROM THE FDA PERSPECTIVE
FOREIGN DRUG INSPECTION/AUDITS FROM THE FDA PERSPECTIVE Robert C. Fish EAS Consulting Group, LLC. Statistics About 80% of world supply of APIs from India and China Some API produced in Korea, but little
More informationEffective Risk Management in Aircraft Leasing and Aviation Finance 2019
Effective Risk Management in Aircraft Leasing and Aviation Finance 2019 Holiday Inn Kensington High Street, London, UK A seminar that will focus on the issues in aviation investment risk management and
More informationResilience Training: Psychological Survival Skills for Before, During and After Crises 8:30 AM - 5:00 PM Glenn Schiraldi
ICISF San Francisco, CA Regional Training Training provided for those beginning their exploration of the field of crisis intervention as well those already serving on CISM teams. Courses not filled to
More informationNEW! Processing of cgmp Controlled Raw Materials
NEW! Processing of cgmp Controlled Raw February 27, 2018 New Brunswick, NJ Directed by: Charity Ogunsanya, (Owner/CEO), Pharmabiodevice Consulting LLC Course Topics Include: FDA Regulations 21 CFR 110.80
More information