Quality Agreements & FDA – What You Must Know to Comply

Teachers
Joanna Gallant
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Regulatory & Compliance/
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Staying abreast of ever changing regulatory requirements with the FDA is not easy.  In November 2016, FDA finalized their guidance on contract manufacturing arrangements for drugs, detailing their expectations for quality agreements.  The final document outlines specific steps manufacturers should make to ensure their contract organizations are living up to a higher standard of compliance.  Additionally, the guidance gives contractors a better understanding of what they really need out of their end of a quality agreement, thus helping them to better position themselves as a viable partner.  Finally, this gives both parties a roadmap to potential inspection/audit points to be aware of.

Don’t wait until an FDA inspection to learn there are deficiencies with your approach to drafting and implementing Quality Agreements!

LEARNING OBJECTIVES

This course will provide an overview and discussion of significant portions of the guidance, where you will learn:

  1. Scope & applicability of the guidance: Defining the who and what of contract manufacturing
  2. What a quality agreement is – and is not
  3. Significant areas of focus for contract manufacturing arrangements
  4. FDA’s perspective on roles and responsibilities – including the first enforcement action highlighting this guidance and other examples
  5. Action plan: A guide for assessing your current quality agreements

Who Should Attend

WHO SHOULD ATTEND

This course will be beneficial to anyone involved in development, implementation, oversight and auditing of quality agreements and/or contract manufacturing arrangements. Those looking to outsource commercial production-related functions, or those who provide outsourced GMP services for commercial products will find this course very valuable.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Joanna Gallant
20+ years of technical and operational experience within pharma, biotech and medical device manufacturing environments.

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