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HomeManufacturing (GMP)Manufacturing Quality Agreements- Actionable Top Tips for Ensuring Consistent Success

Manufacturing Quality Agreements- Actionable Top Tips for Ensuring Consistent Success

Teachers
James Meckstroth
Category:
Manufacturing (GMP)/ On-Demand Courses/ Quality/ Regulatory & Compliance/
Clear
Duration: 60 minutes
On-Demand
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

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.

In this session, industry expert James Meckstroth will provide a fundamental overview of what an effective quality agreement program looks like and how to manage it. Presented from the perspective of active pharmaceutical ingredient and pharmaceutical drug product CMO, James will guide you through a quality agreement framework that may fit into your organization’s vendor/supplier qualification program.

 

LEARNING OBJECTIVES

After attending the 90 minute interactive 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

Who Should Attend

WHO SHOULD ATTEND

This course will be most beneficial to anyone who drafts, has input in, or is affected by Quality Agreements.  Those who work in vendor relations, legal functions, or oversight will find this session of particular benefit.  Also, executives who need to understand the “ins and outs” of Quality Agreements will benefit.

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 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

James Meckstroth
cGMP Quality Assurance/Control Expert

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Clear
Duration: 60 minutes
On-Demand

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