Equipment and Process Change Control - Webinar CD/Transcript

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Equipment and Process Change Control: Manage Changes Correctly and Efficiently

Equipment and process change control is a collection of formal, documented procedures that are used to request, assess, review and formally authorize a change to process, equipment or project. Requirements for such change control are codified in federal law and FDA guidance. This fundamental topic for regulated manufacturing can be complex to the point of utter confusion.

This presentation will break it down and tell you exactly what you need to know to stay compliant and it will help you ensure that when you make changes to your processes or equipment, nothing goes wrong.

Industry expert Vadim Klyushnichenko, Ph.D. will take you through the relevant sections of 21 CFR Subpart F, through a change control flow sheet, and discuss strategies for process development.

He’ll explore what process characterization is, define process parameters and help you determine which are critical and which aren’t.

He’ll talk about how change control applies to transitions such as going from IND to NDA, scaling up or down, or between old manufacturing technologies and new.

Finally, he’ll explore a pair of detailed case studies in change control to show you exactly how these principles work in the real world.

This presentation will teach you:

  • The definitions and explanations of a change control system in the biopharmaceutical industry
  • What the regulatory requirements for change control are
  • What the current process development strategy in the biopharmaceutical industry is and how change control is applied to different phases of drug development and manufacturing
  • How to characterize process and define critical process parameters
  • What kind of technology transfer strategies are applicable for the biopharmaceutical industry
  • Equipment and process qualification and validation as a final step of equipment change control
  • Practical examples of equipment and process changes
  • R&D and Analytical Scientists
  • Process Development Engineers
  • QA managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors

Vadim Klyushnichenko, (Ph.D.) is the President and Founder of Key Pharma Consulting, LLC. Dr. Klyushnichenko has over 15 years of experience in biopharmaceutical project management, analytical development and formulation, drug process development, engineering and scale up to pilot and manufacturing level, international tech-transfer and regulatory filing for oral, injectable, pulmonary drugs and drug/device combinations.

His drug delivery experience includes formulation of proteins and small molecules in micro-crystals, micro- and nano-particles, liposomes, and degradable matrixes as well as the development of controlled-release systems and devices for oral, injectable, implantable and pulmonary delivery. Vadim has developed his growing managerial and scientific responsibilities working as Vice President of Pharmaceutical Development at Coldstream Laboratories Inc.(Lexington, KY), Lab Head/Principal Scientist at Wyeth BioPharma, Sr. Scientist at Epic Therapeutics (Baxter), Altus Biologics (Boston, MA) and Aventis (Sanofi Pasteur, Toronto, ON Canada). Vadim has received his B.S. in Physics from Moscow Institute of Physics and Technology (Fiztech), and Ph.D. in Chemistry from Shemyakin & Ovchinnikov Institute of Bioorganic Chemistry (Moscow, Russian Academy of Sciences). Dr. Klyushnichenko continued his academic research in Analytical Biochemistry and Process Development as DAAD Postdoctoral Researcher at Humboldt University in Berlin and Alexander von Humboldt Fellow at Dusseldorf University (both Germany) as well as Scientist at Biotechnology Research Institute, Bioprocess Sector (Montreal, QC Canada). Vadim is a Certified Professional Project Manager (PMP/PMI) and holds a Certificate of Special Studies (CSS) in Administration and Management from Harvard University.