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.
In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the 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.
Learning Objectives:
After attending the 75 minute webinar, you will be able to:
- Identify FDA regulations and new guidance regarding quality agreements
- Utilize tips to help you manage quality agreements effectively
- Review the pitfalls to avoid when developing your program
- Organize stakeholders, develop a comprehensive document, and initiate
- Implement oversight steps that keep you compliant and on track towards continuous improvement
Why Should You 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.
Topics
- 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
Instructor
Joy McElroy
Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab.
In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her 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.