OPERON STRATEGIST. Technical Consulting & Regulatory Advisory Services. Mobile:
|
|
|
- Constance Greene
- 6 years ago
- Views:
Transcription
1 OPERON STRATEGIST Technical Consulting & Regulatory Advisory Services Anil Chaudhari (CEO) 1 Mobile:
2 Company Profile Operon Strategist is a premier service provider in technical consulting and regulatory advisory. We can assist you for below mentioned services: Turnkey Services. Quality Assurance. Licensing& Certifications. We undertake turn key projects, annual regulatory contract as well as functions on the customized packages as per the need of the clients all over the globe. Contact: Anil Chaudhari (CEO), OPERON STRATEGIST, anil@operonstrategist.com, anilmchaudhari@gmail.com; Mobile:
3 Mission Our purpose is to serve our clients with unique and matchless Quality and regulatory management services for Medical Devices and Pharmaceutical sector to boost their performance, achieving their targets and meeting their customer, technical & regulatory requirements successfully and being cost effective. Contact: Anil Chaudhari (CEO), OPERON STRATEGIST, Mobile:
4 Our Partners & Alliances Corporate Office: P-511, Phase I, 5 th Level, MayurTrade Centre, Chinchwad, Pune, , Maharashtra, India. Alliancewith: MDI Consultants, Inc. 55 Northern Blvd., Great Neck, New York 11021, USA. Partner: Ireland : Tyone, Nenagh, Co. Tipperary, Ireland. Partner: Room 1912, Building No. 1, Hesheng Qilin She, Chaoyang District, Beijing , P.R.China. Contact: Anil Chaudhari (CEO), OPERON STRATEGIST, anil@operonstrategist.com, anilmchaudhari@gmail.com; Mobile:
5 Regulatory Compliance: Handling/Drafting, Drafting compliances, CAPA mgmt and Deviations mgmt. Design and development of Product Troubleshooting handling for : QMS Validations Process etc. Organizational Experience Turnkey Projectshandling right from land selection to regulatory approvals Microbiological Strategies : Handling of Analysis, Microbiological tests methods Microbiological aspects of Clean room Validation: Equipment Contact: Anil Chaudhari (CEO), OPERON STRATEGIST, anil@operonstrategist.com, anilmchaudhari@gmail.com; Mobile: (k) CE marking ISO 9001 / ISO 13485/21 CFR Part 820: Conceptualization Documentation Training Implementation, Handling Utilities, Process, Analytical methods Strategy Planning, Protocol development, Implementation. 5
6 Sr. No. ServicesDescription: Establisment, Construction& Installation Activity Description Client Benefits 1 Layout Design Preparation 2 Facility construction 3 DRUG license approved From FDA Technical team collects data and prepares designs as per FDA/Local Regulatory Body norms Weassist during the facility build up for selection and positioning of utilities and machineries. The period required for getting approved Drug license depends on the outcome of FDA audits Designed as per National or International Regulatory rules and legislations. Detailed Study of FDA laws & regulations We assist you throughout the project execution time. Our designed are superior and better than the best. Our rejection/objection rate is nil. * We help,for, Verificationof facility layout designs feasibility while installation of machinery,negotiation with Suppliers/ Dealers. 6
7 Services Description: Documentation Documentation Services: Sr.No. Services: Benefits Our Speciality (i) Standard Operating Procedures (SOP) (ii) Validation Protocols & Validation Reports (iii) Site Master File (SMF) (iv) Device Master File (DMF) (v) Technical File ( TF ) for CE marking Designed as per the latest National or International Regulatory rules and legislations. Detailed Study of FDA and Local Regulatory Body laws& regulations. Our Technical team conducts gap analysis, identifies preliminary and final stage requirements and collects the data accordingly. Strong Technical competency. Liable for technical responsibilities. We assist you throughout the project execution time. 7
8 Services Description: System Implementation Sr. No. Services Benefits Insights 1 System Implementation QMS as per: ISO 9001:2008 ISO 13485: CFR -Part 820 It covers: Training System monitoring Handling MRM Handling CAPA Handling Deviations Internal Audits 8
9 Services Description: Activities, Monitoring & Guidance Sr. no. Parameters a) Equipment Utilities & Validation Requirement (for example). Clean Rooms, Sterilizers, Microbial, Microbial, Cleaning, Analytical. b) Qualification Installation Qualification /Operation Qualification/Performanc e Qualification. c) Certification ISO 9001:2008 (QMS), ISO 13485:2003 (Medical Devices), cgmp, CE Marking Consultancy, USFDA, 510 (k) d) Training cgmp, QMS (ISO 9001:2008), training to labours. Client Benefits Best use of available land area to achieve the maximum space utilization Time to time testing and inspection of machinery always keep an eye on the machinery efficiency and thus save clients huge financial losses Implementation of best management system practices acts as a tool to achieve larger benefits and makes your system run more effectively and efficiently Our Specialty Strong Technical Competency Time to Time assistance to clients Thorough knowledge of various National and International standards Our Charges/Fees is very affordable Free training to all laboursin the company to understand the implementation process of QMS 9
10 Confidentiality Statement We obtain and collect data from various organisations which may or may not be confidential in nature. Asapolicyofourcompany,weareboundtomaintainallthecommercial,data,technical data are kept highly confidential. Sharing confidential information is prohibited or concerned information is made available as per after granting consent from respective authorities. 10
11 Quality by design. Contact: Anil Chaudhari (CEO), OPERON STRATEGIST, Mobile: , 11
Drug 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
Anushri Global Pharma Consultants
Anushri Global Pharma Consultants Your Knowledge Partner In Training, Consulting & Placement Anushri Global Pharma Consultants A Catalyst to sustainable growth Page 1 of 9 About Us Training is important
Prequalification Team WHO PUBLIC INSPECTION REPORT Vaccine Manufacturer
Part 1: General information Name of Manufacturer Production Block Physical address Contact address Prequalification Team WHO PUBLIC INSPECTION REPORT Vaccine Manufacturer. Clean Utilities in the Basement.
Quality Manual. Index
This quality policy manual is for the use of, its Clients, Vendors, and the appropriate Regulatory Agencies. Unauthorized duplication or transfer to others is prohibited. Index Authorization... 3 Introduction...
TRAINING, AUDITING, INTERIM MANAGEMENT AND CONSULTANCY
GMP SERVICES TRAINING, AUDITING, INTERIM MANAGEMENT AND CONSULTANCY PCS was founded in 1990 with one simple mission: help companies struggling with GMP in achieving regulatory compliance. We have maintained
Journal home page: RESEARCH ARTICLE
Journal home page: http://www.journalijiar.com INTERNATIONAL JOURNAL OF INNOVATIVE AND APPLIED RESEARCH RESEARCH ARTICLE QUALITY AUDIT AND GMP INSPECTION OF PHARMACEUTICAL INDUSTRY WITH REFERENCE TO USFDA;
QUALITY AGREEMENT. The following Agreement has been concluded between
QUALITY AGREEMENT The following Agreement has been concluded between LLC LABORATORIES The contract laboratory and service provider 1625 Trinity Dr., Unit 11 Mississauga, Ontario Canada L5T 1W9 Hereinafter
What Is ISO-13485/ MDD 93/42/EEC, FDA cgmp Systems Validation Protocol?
ATL Pharmaceutical/ Medical What Is ISO-13485/ MDD 93/42/EEC, FDA cgmp Systems Validation Protocol? Leaders in Pharmaceutical and Medical Converting SYSTEMS VALIDATION PROTOCOL INCLUDES ALL OF THE ELEMENTS
KINGSMANN CARE GROUP
PHARMA CONSULTANTS KINGSMANN CARE GROUP KINGSMANN CONSULTANCY SERVICES Thank you for taking interest in Kingsmann Consultancy Services. Kingsmann Consultancy (KC) is a leading business development-consulting
An Introduction to Double Dragon Consulting
An Introduction to Double Dragon Consulting www.doubledragonconsulting.com 1 June 2012 About DDC Our Experience: All dosage forms, aseptic processes, OTC Remediation of 483 observations, warning letters,
Curriculum Vitae. SENIOR VICE PRESIDENT JAMES P. KULLA Mobile Phone:
Curriculum Vitae SENIOR VICE PRESIDENT JAMES P. KULLA Mobile Phone: 240.413.3350 Summary of Qualifications Jim has been active in the medical products industry since 1967. Jim founded a company in 1980
GMP The Other Side of Chemistry, Manufacturing & Controls (CMC)
Overview of USFDA Drug Regulatory Requirements Pharmaceutical Quality and Facility Inspections (GMP) Session II 19 February 2014 Casablanca, Morocco GMP The Other Side of Chemistry, Manufacturing & Controls
The 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
Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances
Performing Multiple Regulatory Requirements within a Program Such as GMP, GLP, GCP, Medical Devices, and/or Controlled Substances Performing Multiple Regulatory Requirements within a Program Such as GMP,
GxP 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
FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru
FDA 21 CFR Part 820 vs. ISO 13485:2016 Comparison Table created by greenlight.guru FDA QSR (21 CFR Part 820) ISO 13485:2016 820.1 Scope 1 Scope 2 Normative References 820.3 Definitions 3 Terms and Definitions
Robbie Morehead Project Manager
Profile The consultant is an accomplished quality professional with 27 years' extensive medical device, pharmaceutical, regulatory, and Food and Drug Administration (FDA) experience. The consultant s experience
(MPY-201 DRA) - ADVANCE DRA I
(MPY-201 DRA) - ADVANCE DRA I (Indian Legislation) The Drugs and Cosmetics act, 1940 and Rules with emphasis on Good laboratory practices and requirements of premises and equipments (Schedule L-I), Good
Regulatory Affairs, Compliance Assurance, Quality Systems, Remediation Strategy and Support, and Strategic Consulting Services
Regulatory Affairs, Compliance Assurance, Quality Systems, Remediation Strategy and Support, and Strategic Consulting Services At Regulatory Compliance Associates Inc. (RCA) we understand the complexities
Quality Management System MANUAL. SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702
Quality Management System MANUAL SDIX, LLC Headquarters: 111 Pencader Drive Newark, Delaware 19702 Doc. No. G5500 Rev. 11 Status : APPROVED Effective: 09/07/2017 Page 2 of 32 Quality Manual Table of Contents
GxP 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
GxP 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
CUSTOMER AND SUPPLIER ROLES AND RESPONSIBILITIES FOR 21 CFR 11 COMPLIANCE ASSESSMENT. 21 CFR Part 11 FAQ. (Frequently Asked Questions)
21 CFR Part 11 FAQ (Frequently Asked Questions) Customer and Supplier Roles and Responsibilities for Assessment of METTLER TOLEDO STARe Software Version 16.00, including: - 21 CFR 11 Compliance software
MEDICAL DEVICES. Medical Device Manufacturing License. Facility Layout Design as per various regulatory requirements. Clean room and HVAC consultation
MEDICAL DEVICES With more than 100,000 individual medical devices on the market, patients have access to an astonishing array of products that can improve health and extend life. But the safety concerns
An 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
Pharmaceutical 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
Strategies to Revise Quality Policy and Quality Objectives. Eileen Cortes February 22, 2017
Strategies to Revise Quality Policy and Quality Objectives Eileen Cortes February 22, 2017 Agenda Elements of Compliance Quality Policy Outline Quality Strategy and Objectives Case Study Open Discussion
Zydus Hospira Oncology Pvt. Ltd.
Company, Position & Person Profile Zydus Hospira Oncology Pvt. Ltd. 6/7/15 About Zydus Hospira Oncology Pvt. Ltd. Zydus Hospira Oncology Private Limited (ZHOPL) is a joint venture company in Ahmedabad,
MASTER PLANNING FOR VALIDATION
MASTER PLANNING FOR VALIDATION By: Gamal Amer, Ph.D. Principal, Premier Compliance Services, Inc. 1 Process Validation: General Principles and Practices Guidance to industry issued by the FDA in January
Where Quality Meets Flexibility
Where Quality Meets Flexibility is an industry leading 503B Outsourcing Facility providing sterile and non-sterile compounding services to hospitals, surgery centers, clinics, researchers & patients nationwide.
Life Sciences Courseware. Knowledge. Performance. Impact.
Life Sciences Courseware Knowledge. Performance. Impact. Now there s a flexible, affordable way to achieve your compliance training goals. In the Life Sciences industry, it s vital that your people are
Controlled Environment Commissioning and Qualification Using a Phased Approach to meet schedule demands
Controlled Environment Commissioning and Qualification Using a Phased Approach to meet schedule demands Michael Marino, Sr. QE Effectively Integrating C&Q with Construction & Startup Activities Setting
Your Complete Quality Solution Provider for the Life Science Industry
Your Complete Quality Solution Provider for the Life Science Industry PQE at-a-glance Our broad services portfolio, extensive experience, effective project management, and exceptional cost effectiveness,
DECISION TO ACCREDIT
DECISION TO ACCREDIT Determine the requirements of the regulator, legislation and customer s needs prior to deciding on the standard to implement. Process is based on the following: Top management s decision
Pharmaceutical cgmps for the 21st Century February 2004
Pharmaceutical cgmps for the 21st Century February 2004 Ludwig Huber Compliance Fellow for Life Sciences and Chemical Analysis Chairperson: Rob Sample FDA GxP Regulations Along the Drug Life Basic Research
Wilson-Hurd ATF Quality Manual
Wilson-Hurd ATF Quality Manual Wilson-Hurd Manufacturing Company Advanced Technical Facility (ATF) 311 Winton Street Wausau, WI 54403 Rev. Date: 04 May 2017 Pete Dehne Vice President, Operations Table
SITE MASTER FILE For MHRA
ABC CO., LTD. For MHRA Prepared by Date Approved by Date Verified by Date Document No.: SMF, Version No: 01, Effective Date: 09/05/06 Document No.: SMF Version No.: 01 Effective Date: 09/05/06 Page 2 of
Prevent 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
Annex 13 WHO guidelines for preparing a laboratory information file
World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 13 WHO guidelines for preparing a laboratory information file Background The WHO Expert Committee on Specifications for Pharmaceutical
Corporate Presentation
Corporate Presentation 1 Development Tool Medicine Stabicon Life Sciences Wellness Health Supplement Ethos Vision: Lead the way to a healthier world by partnering with Pharmaceutical Community across the
MDI Manufacturing Services
MDI Manufacturing Services Presenter, Date Who we are 3M Drug Delivery Systems is a division of 3M dedicated to working together with pharmaceutical and biotech companies to bring new and improved products
3M Drug Delivery Systems. April 26, 2011
3M MDI Manufacturing April 26, 2011 3M Drug Delivery Systems Drug Delivery Systems Overview 3M Drug Delivery Systems is a division of 3M that is dedicated to the development and manufacturing of inhalation
Accuratus Lab Services Quality Manual. Revision 003. Index
This quality policy manual is for the use of, its clients, vendors and the appropriate regulatory agencies. Unauthrized duplication or transfer to others is prohibited. Index Authorization... 3 Introduction...
National Animal Supplement Council
NASC established a Preferred Supplier Program for companies who wish to provide products and services to NASC member companies, including raw materials (ingredients), contract manufacturing (dosage form
Overview of Regulatory Requirements for API and Formulations
Overview of Regulatory Requirements for API and Formulations Sangeeta Sardesai 4-Dec-2010 Definition - Regulatory Requirement The restrictions, licenses, and laws applicable to a product or business, imposed
Position Description
Position Description Position: Location: Department: Reports to: Status: Senior Project Manager Gold Coast Planning and Projects General Manager Planning and Projects Full Time Purpose of the role: The
Subpart 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
EUROPEAN INDUSTRIAL PHARMACISTS GROUP. Guidance on CPD for QUALIFIED PERSONS
EUROPEAN INDUSTRIAL PHARMACISTS GROUP Guidance on CPD for QUALIFIED PERSONS EIPG Guidance on CPD for QP Continuing Professional Development for Qualified Persons, Technical Directors and other Responsible
Zydus Hospira Oncology Pvt. Ltd.
Company, Position & Person Profile Zydus Hospira Oncology Pvt. Ltd. 6/7/15 About Zydus Hospira Oncology Pvt. Ltd. Zydus Hospira Oncology Private Limited (ZHOPL) is a joint venture company in Ahmedabad,
Prequalification Team WHO PUBLIC INSPECTION REPORT (WHOPIR) Active Pharmaceutical Ingredient (API) Manufacturer
Prequalification Team WHO PUBLIC INSPECTION REPORT (WHOPIR) Active Pharmaceutical Ingredient (API) Manufacturer PART 1: GENERAL INFORMATION Name of Manufacturer Calyx Chemicals & Pharmaceuticals Ltd Unit:
Zydus Hospira Oncology Pvt. Ltd.
Company, Position & Person Profile Zydus Hospira Oncology Pvt. Ltd. 6/7/15 About Zydus Hospira Oncology Pvt. Ltd. Zydus Hospira Oncology Private Limited (ZHOPL) is a joint venture company in Ahmedabad,
AAMI 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
Job description. Career Level Career Level 3. Hours/sessions per week 37.5 INTRODUCTION
Job description Job title Directorate Compliance Engineer Engineering Career Level Career Level 3 Responsible to Base/location Process Engineering Manager Porton Down Hours/sessions per week 37.5 Job type
ABB Industries PAT Validation
Alison Harrington ABB Industries PAT Validation ABB Industries - 1 - Topics PAT disciplines and framework FDA evolution PAT Regulatory Process Quality System Comparability Protocol Submission example Validation
QUALITY UPDATE Q1 2018
QUALITY UPDATE Q1 2018 QUALITY LEADERSHIP Dear Valued Customer, At SCA Pharmaceuticals, Quality is the cornerstone of our business. I am pleased to provide you with our first Quality Report of 2018 which
Role of Industrial Engineer in Compliance with FDA Regulations
Role of Industrial Engineer in Compliance with FDA Regulations Wanda J. Torres Medical Device Specialist Libia M. Lugo Drug Specialist Simposio de Ingeniería Industrial Polytechnic University, San Juan
Experience responsibility. Pharmaceuticals & Biotechnology. GMP Compliance
Experience responsibility Pharmaceuticals & Biotechnology GMP Compliance Everything you need for GMP Compliance! Systems, processes, personnel and documentation that affect the product quality and product
Drug and Device Makers Cited in 483s for CAPAs, Poor Documentation in 2014
Drug and Device Makers Cited in 483s for CAPAs, Poor Documentation in 2014 Copyright 2015 by FDAnews. All rights reserved. Photocopying or reproducing this report in any form, including electronic or facsimile
Brief Introduction of Aburaihan Company Organization Policy Organization Chart Qualified Human Resource Production Department Engineering Department
1 Contents Brief Introduction of Aburaihan Company Organization Policy Organization Chart Qualified Human Resource Production Department Engineering Department Sanitation and Environment Protection Documentation
The Impact of Quality Culture on Quality Risk Management. FDA Perspective on Quality Culture; how it Impacts Risk Management
The Impact of Quality Culture on Quality Risk Management FDA Perspective on Quality Culture; how it Impacts Risk Management Teresa Gorecki Practice Lead Compliance Architects Agenda The WHAT Definitions
Engineering & Validation Training Program
MAPAQ Engineering & Validation Training Program PBE, Pharma Bio Expert Inc PBE-Expert Inc CANADA PBE is a Training Company with Agreement CPMT #0059104 PBE, Training Company Agreement CPMT #0059104 2 MAPAQ
International Journal of Pharmaceutical and Medicinal Research
Review article A review on process validation Int. J. Pharm. Med. Res. 2014; 2(3):100-104 ISSN: 2347-7008 International Journal of Pharmaceutical and Medicinal Research Journal homepage: www.ijpmr.org
QUALITY SYSTEMS INSPECTIONS TECHNIQUE
QUALITY SYSTEMS INSPECTIONS TECHNIQUE Notice: This draft document represents the Agency' current thinking on the subject of Quality System Inspections. It is provided to the public in order to stimulate
The ABCs and Challenges of GMP The American Experience
The ABCs and Challenges of GMP The American Experience The Canadian Association of Nuclear Medicine Toronto, Ontario April 22, 2017 Reiko Oyama, R.Ph., B.C.N.P. Washington University School of Medicine
Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider
DPT Thought Leadership Issue 2 Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider I N T R O D U C T I O N In recent years, the pharmaceutical industry has given greater
Company, Position & Person Profile. Cadila Healthcare Limited
Company, Position & Person Profile Cadila Healthcare Limited About Zydus Cadila Zydus Cadila is a fully integrated, global healthcare provider, with strengths all along the pharmaceutical value chain.
DFUG 2015 Audit Report
presents DFUG 2015 Audit Report Michael Holdsworth Phil Kirsch Overview The DataFax User Group (DFUG) vendor audit is a combined user group audit that allows DataFax users to determine whether DF/Net Research
Change Control Overview
Change Control Overview Kelly Thomas Atlantic Technical and Validation Services Copyright 2014 by Atlantic Technical and Validation Services, LLC. 1 Session Outline Discuss Regulations Governing Change
Effective Management and Operations of GXP Laboratories
Effective Management and Operations of GXP Laboratories Course Objective: Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory / Good Manufacturing Practice
SADCAS POLICY ISO/IEC 17020:2012 TRANSITION
SADCAS POLICY ISO/IEC 17020:2012 TRANSITION Prepared by: SADCAS Approved by: SADCAS CEO Approval Date:2012 09 25 Effective Date: 2012 10 01 Page 1 of 11 Table of Contents Page 1. INTRODUCTION... 3 2. TRANSITION
Demystify Governance, Risk & Compliance For Lifesciences
www.hcltech.com Demystify Governance, Risk & Compliance For Lifesciences Competitive global markets, more-demanding patients, regulations from multiple regulatory authorities and high product development
Job description. Job title. Process Engineer. Career Level 3. Responsible to. Process Engineering Manager. Hours/sessions per week 37.
Job description Job title Directorate Process Engineer Production Career Level 3 Responsible to Base/location Process Engineering Manager Porton Hours/sessions per week 37.5 Job type Permanent INTRODUCTION
Developing an Internal Quality Auditing Program
Developing an Internal Quality Auditing Program SeerPharma Pty Lt Capsig August 2009 1 Critical Success Factors Culture of Compliance Integrate quality systems and risk management principles Well defined
Supplementary Training Modules on Good Manufacturing Practice. Validation. WHO Technical Report Series, No. 937, Annex 4.
Supplementary Training Modules on Good Manufacturing Practice Validation WHO Technical Report Series, No. 937, 2006. Annex 4. Validation Slide 1 of 48 August 2006 Validation! Part 1. General overview on
Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities
Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities audit, audit report and CAPA 1. QUALITY must be guaranteed,
Webinar Expert Module 3: GMP Inspections Dupont
Webinar Expert Module 3: GMP Inspections Dupont 26 January & 9 February 2018 GOP-Innovations your Partner for Practical Training and e-learning Milenko Pavičić Pharmaceutical microbiologist, trainer, coach
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
FSMA Information & Compliance for Fuel Ethanol Producers
FSMA Information & Compliance for Fuel Ethanol Producers Compli Associates 605.254.1077 compli@compliassociates.com www.compliassociates.com About Compli Associates Compli Associates specializes in developing
V. S. International Pvt. Ltd
V. S. International Pvt. Ltd Innovation in medicine Partners In human care for today and tomorrow... Unit I - Daman V. S. International is a Healthcare Company with it s Corporate Head office at Mumbai,
Validation Boot Camp. Validation Fundamentals: Conducting a Successful Validation Project
Validation Boot Camp Validation Fundamentals: Conducting a Successful Validation Project Learning Objectives Upon completion of this workshop, participants will be able to: Understand FDA and GMP terms
Quality Agreements with CMO s. Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality
Christian Gausepohl, Frank Böttcher. GMP Focus. Managing Contract Manufacturers and Testing Labs. PDF Download. Excerpt from the GMP MANUAL
Christian Gausepohl, Frank Böttcher GMP Focus Managing Contract Manufacturers and Testing Labs PDF Download Excerpt from the GMP MANUAL Bibliographic Data of the Deutsche Nationalbibliothek: http://dnb.ddb.de
FDA s Role in Vaccine Supply
IOM Committee on Review of Priorities of the National Vaccine Plan Stakeholder Workshop #1 24 July 2008 FDA s Role in Vaccine Supply Norman W. Baylor, Ph.D., Director Office of Vaccines Research and Review
Cambridge Commodities Ltd QUALITY MATTERS
Cambridge Commodities Ltd QUALITY MATTERS contents Quality at CCL Meet the quality team New supplier and material approvals FTIR investigation Positive release Repack process Regulatory and technical support
ASQ 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
Your Partner Of Choice For Global Pharma Compliance. Corporate Presentation
Your Partner Of Choice For Global Pharma Compliance. Corporate Presentation Vision We aspire to be a partner of choice for global compliance & project management across the pharmaceutical value chain,
Clause Map IATF 16949:2016 to ISO/TS 16949:2009
Table of Contents Table of Contents Foreword Foreword + Foreword Automotive QMS Standard + History + Goal + 0.5 Goal of this Technical Specification + Remarks for Certification + Remarks for Certification
Zydus Hospira Oncology Pvt. Ltd.
Company, Position & Person Profile Zydus Hospira Oncology Pvt. Ltd. 6/7/15 About Zydus Hospira Oncology Pvt. Ltd. Zydus Hospira Oncology Private Limited (ZHOPL) is a joint venture company in Ahmedabad,
BCS Organizational Chart
BE&K Validation BCS Organizational Chart Business Development Mgr. Dwight Rivera President Accountant QA and Compliance Technical Services Engineering / Manufacturing Packaging and Inspection Sr. QA Sr.
Job Description. To participate in department shifts including early and late cover, night duties and weekends as required.
Job Description Job Title: Location: Reporting to: Accountable to: Senior Biomedical Scientist Microbiology, TDL North West London Deputy Head of Microbiology Head of Microbiology Job Summary: In co-operation
Curriculum Vitae Dr. Joachim Schoch-Bösken. jsb-validierung Zwischen den Bächen 9 D Rheinfelden
Personal Data Name Title Validation Consultant Contact jsb-validierung Zwischen den Bächen 9 D 79618 Rheinfelden Tel: +49 7623 79 49 82 Mobile: +49 176 42 60 85 72 E-Mail: Internet: jsb-val@online.de http://www.jsb-validierung.de
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
Combination Products Part 4 Compliance and Implementation at multi-site Network
Combination Products Part 4 Compliance and Implementation at multi-site Network Vijay Damodaran Eli Lilly & Company September 27, 2017 Contents Key cgmp requirements for combination products How to perform
NUSAGE 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
September 2, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
September 2, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA Draft Guidance: Current Good Manufacturing Practice Interim
IDT Australia Ltd. 5/23/18
IDT Australia Ltd. 5/23/18 10903 New Hampshire Avenue Silver Spring, MD 20993 Via UPS Warning Letter 320-18-55 Return Receipt Requested May 23, 2018 Dr. Graeme R. Kaufman CEO, Acting, and Chairman of the
Enabling Improvement through the Product Lifecycle: Change Management within a PQS
Enabling Improvement through the Product Lifecycle: Change Management within a PQS Denise DiGiulio, Senior Advisor OPQ Office of Process and Facilities PDA Chapter Meeting Melbourne, Australia April 3,
Transition Strategy for VDA 6.1, VDA 6.2 and VDA 6.4. Revision January Contents. 1. Foreword
Transition Strategy for.1,.2 and.4 Revision 1.0 --- 06. January 2017 Contents 1. Foreword 2. Transition timing requirements to the relevant.x standards 3. Transition audit requirements to the relevant.x
Lessons from Pharmaceutical Laboratory related FDA Warning Letters
Lessons from Pharmaceutical Laboratory related FDA Warning Letters The Agilent Critical Compliance Seminar 2016 Ludwig Huber Ludwig_huber@labcompliance.com Overview FDA Inspections and reports GMP compliance