Quality Agreements & FDA – What You Must Know to Comply with the 2016 Final Guidance

Date: March 23, 2017
Duration: 90 Minutes - Online
Price: $299 - Includes Bonus Handouts!

Course Description:

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

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

What You'll Get:

As with all LSTI courses, you can expect expert instruction with plenty of interactivity in addition to:

  • Bonus documents which can take the form of job aids, regulatory documents, checklists, templates, and more!
  • Contact information for your instructor for questions after the fact

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.

Joanna Gallant is an experienced, solutions-driven Quality professional with over 20 years of technical and operational experience within pharmaceutical, biotechnology and medical device manufacturing environments.  Over her career she has provided regulatory, technical, skill and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management.

Joanna has held positions in quality assurance, laboratory and training roles. She has established and led multifunctional and global project teams, and worked both as an individual contributor and a manager, and can speak from various perspectives as a result.  She is well versed in instructional systems design and possesses highly efficient analytical problem solving and root cause analysis skills, which she uses to identify problems and solutions for performance and process improvement, and to analyze training systems for gaps and training programs for effectiveness.  She has demonstrated the ability to drive culture change and accountability through training and to inspire change and continuous improvement at the operator level as well as through management.  Joanna has successfully represented the training function to regulators from around the world, and quickly develops a positive rapport with auditors.

Joanna regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based training, regulatory requirements, and interactive training design.  She has been in leadership positions in the Massachusetts-based BETA organization for the last 10 years, and was invited to join the GMP TEA, Inc. Board of Directors in 2008. She is one of the founders of and an instructor in the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.