Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. FDA issued dozens of 483 observations relating to topics governed by the quality agreement system in the past. Furthermore, FDA finalized the "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry" document.
Due to this new guidance, you can be sure that your firm's quality agreement will receive increased scrutiny, leaving you vulnerable to the risk of non-compliant GMP products and services if your agreements aren't clear and enforced. Join expert speaker Joy McElroy in this webinar to understand & ensure compliance for your organization.
Session Highlights:
Regulatory requirements for supplier qualification
Responsibilities of manufactures and suppliers
The who and what of a good Quality Agreement
What a Quality Agreement is - and is not
What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
Responsibilities of the owner vs. contract facility
GMP responsibilities
Best practices for a good quality agreement
A comparison of the new guidelines from the FDA and the EU
Documentation requirements and audit trails
Why You Should Attend:
In this session, industry expert Joy McElroy will provide a fundamental overview of what an effective quality agreement program looks like and how to manage it. Joy will guide you through a quality agreement framework that may fit into your organization's vendor/supplier qualification program. This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective. Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration.
Who Should Attend:
Quality Assurance
External Manufacturing / Outsourcing
Quality Auditing
Technology Transfer
Regulatory Affairs / Compliance
Supply Chain
Purchasing
Risk Management
Managers and QA personnel from Contract Manufacturing Organizations (CMOs)
*You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it as per your convenience.
Joy Mcelroy
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Joy work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 she moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, she moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 14 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, she has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing.
She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. She develops and delivers webinars, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more. Joy also writes articles on these topics for various online magazines.In 2013 she started my own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.