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Feb 26
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09:00 - 17:00 480 mins
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Pre-Conference Workshop #1: Preparing for an FDA Inspection
Pre-Conference Symposium #1: Preparing for an FDA Inspection
  • Scott Wheelwright, PhD - Co-Founder, Complya Asia Co., Ltd.

Objective:
The objective of this course is to provide participants with the information they need to implement and operate a Quality Management System that meets the expectations of international regulatory agencies.

Trainer:
Dr. Wheelwright is founder of Complya Asia Co., Ltd., a consultancy focused on improving the quality of pharmaceutical practice in China.  Dr. Wheelwright was founding Chief Operations Officer with Innovent Biologics, one of the leading biopharmaceutical development companies in China.

Dr. Wheelwright has been an executive officer in several biotech startups, and has supervised the areas of manufacturing, process development, compliance, quality assurance, quality control, validation, engineering and facilities.  He has worked as a researcher in the laboratory and has led the development of several products that are now on the market.  He has led the construction of multiple manufacturing facilities that meet the international compliance requirements for current Good Manufacturing Practice (cGMP).

Dr. Wheelwright has over 30 years experience in solving the challenges companies encounter when bringing biotech, pharmaceutical, and other medical products out of research and into the commercial marketplace.

Overview:
Developing and implementing Quality programs that meet international expectations is a challenge for many companies.  Part of the challenge is understanding the requirements of foreign regulatory agencies.  Another challenge is changing the way of thinking of employees to recognize how they can always be in compliance (yes, this is possible!).

In this training you will be taught what you need to do to ensure your quality system is in compliance with international standards for Quality Assurance.  We will go through each of the Quality Management Systems and identify common issues and how to overcome them.  We will discuss the problems companies face in presenting their compliance performance to inspectors and how to help inspectors understand our true level of compliance. 

This hands-on course will provide you with an understanding of:

  • how to work with FDA and EMA inspectors
  • how to develop Quality Management Systems that meet international requirements
  • QMS document requirements
  • operating procedure requirements
  • facility and equipment requirements
  • Quality Control requirements
  • what is compliance and what does it mean to be in compliance
  • what are the requirements for compliance
  • how do we develop a quality mindset among all levels of employees
09:00 - 17:00 480 mins
Info
Pre-Conference Workshop #2: The Essentials of Technology Transfer
Pre-Conference Symposium #2: The Essentials of Technology Transfer
  • Instructor Richard Dennett - Senior Director Regulatory Affairs CMC, PPD

Virtually every company will need to outsource certain factors over the course of its drug product development; whether it be analytical and process development, cGMP contract manufacture, characterization and viral clearance testing, validation, regulatory support etc.  This is underpinned by Technology Transfer.

Principal junctures of Technology Transfer can occur between pre-clinical to first into human (FIH), successive clinical stages and through to commercial manufacture.

Technology transfer elements can be complex and in today’s fast-moving field of drug development there can be no room for error, with associated cost and delay implications. Technology transfer lies directly on the critical path and therefore must be right ‘first time’. Demonstration of Product Comparability forms an essential element of certain technology transfer situations and which is essential in ensuring an exacting clinical product and meeting regulatory expectation.

In this workshop we will examine essential technology transfer as it applies to multiple product types (recombinants, biologics, vaccines, cellular and gene therapy products, conjugates etc.) and

  • The nature of the challenge
  • Strategy
  • The ‘nuts and’ bolts of technology transfer
  • Application to different product types recombinants, mAbs, biologics, ATMPs, biosimilars etc.
  • Considerations of early and late stage transfers
  • Pre-clinical to FIH
  • cGMP manufacture
  • The importance of the quality target product profile
  • Ensuring Product Comparability
  • Change control
  • Regulatory compliance and health authority expectation
  • Managing risk
  • Sourcing and selection of a CMO partner
  • Project management
  • Technical and Quality agreements, protocols and reports
  • Dealing with issues and how to get things back on track
  • In licensing
  • Commercial strategy
  • Common pitfalls

The workshop will incorporate a mix of interactive modules, real life case studies, key topic points for discussion plus will provide model examples of actual technical quality agreements, technology transfer protocols and reports.

Instructor: Richard Dennett, Senior Director Regulatory Affairs CMC, PPD, France