Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries

  Product ID : JOYM-0014

  Level : Intermediate

  Duration : 90 Minutes

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia &UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab.  In 1998 Joy 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, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries.  Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

In 2019 she opened her own company, McElroy Training, and Consultancy, LLC which provides consultants for various projects as well as on and off-site training to pharmaceutical and biotech companies throughout the United States.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams through implementing 5 simple techniques she has learned and applied through the years.

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

  • 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

Areas Covered

  • Regulatory requirements for supplier qualification
  • Responsibilities of manufacturers 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

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)

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.

  • $200.00

Recorded / Download Access