The New FDA Guidance on Quality Agreements and Effective Management of Contract Manufacturing

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Peter Calcott Ph.D. Biography>>>

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When you are a virtual or partially virtual company and outsource your supply chain (raw material procurement, manufacturing, packaging and labeling) to a third party, you may delegate the physical activity for these operations to that company. However, you are still ultimately responsible for the operation and are accountable to the agency to assure that all activities are conducted according to regulations, procedures and policies and your license. With the issuance of guidance by the FDA on quality agreements in May 2013, the path is clearer but the execution requires more of the practitioner than previously envisioned. This presentation will describe what the guidance says and describe strategies and tactics with concrete examples of how you can set up quality systems that will assure compliance and successful operations that will satisfy the agencies. It will take the ambiguities of the guidance and clarify them, giving you the tools to assure successful operations. Failure to implement systems to oversee the contract manufacturer can result in poor operational efficiencies and slowness in dealing with issues as they arise including releasing products to market, change control, deviations and investigations, documentation, validation, procurement and management of raw materials and label control. Effective communication between both parties is critical especially in managing change and performing the Annual Product Review, whereas poor communication can result in release of products with deficiencies resulting in recalls and other regulatory challenges. Based on warning letters in 2009 into 2015, overseeing contractors is still a major issue with companies.

This live training webinar will provide valuable information on what the agencies expect of a pharma/biotech company when they outsource some or all of their supply chain activities to a third party. It will describe how to develop and implement a successful Quality Agreement that meets your business needs as well as satisfy the FDA and other regulatory bodies. This includes your obligations for oversight of the contract manufacturer and what the FDA, EMA and Canadians expect of you. It also highlights some common errors that companies fail to correct. It describes the elements of the Quality Agreements which are now being suggested by the FDA via guidance but which is required by the EMA. It describes what oversight means in simple terms and how to get to that state with your contractor. It gives you an understanding of the shared responsibilities of both parties and how to work cooperatively to common shared goals. It describes the timing for the activities required for a successful intercompany relationship. This live training webinar describes situations where outsourcing makes sense and when it does not, including the real cost of the relationship.

Learning Benefits:
The whole process of when and if to outsource your manufacturing operations is complex but with the step by step process described, you will learn;
- What the new May 2013 FDA Guidance says and what it means
- What an effective Quality agreement looks like and what it contains
- How to set up a win-win relationship with your contractor and operations that you both can live with
- What your obligations are from a regulatory perspective as a virtual company especially in light of the new FDA guidance on quality agreements
- What the key processes you must have in place, how to document them in the Quality Agreement and how to monitor their effectiveness
- What the real cost of outsourcing is and where you cannot cut corners
- When to outsource and the watch outs that can occur
- How companies fail in their oversight of their contractors

Regulations that will be Covered:
Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to the inspection and response processes and philosophy:
Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA as well as the new FDA Guidance on Quality Agreements
EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
International Conference on Harmonization Quality Series Q1 through Q10 for USA, EU, Japan and other countries.

Webinar outline and time breakdown:

09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Reasons for using a CMO,
Foundations in setting up a working relationship and effective communication between parties,
Logistics role versus Quality,
10:30 AM Break
10:40 AM The Quality Agreement and meeting the requirements of the FDA Guidance,
Manufacturing elements,
Quality control issues,
Quality Assurance elements,
Compliance and auditing,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

  • Senior management
  • Quality Assurance personnel and management
  • Quality Control personnel and management
  • Compliance auditors and management
  • Manufacturing management and scientists
  • Supply Chain and Logistics managers
  • Regulatory Affairs Professionals
  • Project Managers working in the CMC arena
Schedule & Deliver this Live Training Webinar Privately to Your Group

Instructor: Peter Calcott Ph.D.

Peter H. Calcott, Ph.D. is President, Calcott Consulting which is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance and enterprise e-solutions. He is also an Academic Program Developer for the University of California, Berkeley’s Biotechnology and Pharmaceutics Postgraduate Programs. Prior to this he was VP at the executive team level at PDL BioPharma where he was responsible for development and implementation of Quality & Compliance strategy across the corporation… Full Bio>>>



Course Number: 307

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland