Equipment and Process Change Control in Bio/Pharmaceutical Industry

Instructor: Vadim Klyushnichenko (Ph.D.)
Product ID: 701365
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This Equipment & change controls training review the definitions of change controls,types of changes,documentation,principles of process development, design of experiments,types of technology transfers and project management aspects of change control

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. This presentation will review the definitions of change controls, types of changes, documentation, principles of process development, design of experiments, types of technology transfers as well as project management aspects of change control. Several case studies will present typical examples of process and equipment change control, which improved the quality of final product.

Areas Covered in the seminar:
  • Definitions and explanations of change control system in Bio/Pharmaceutical industry
  • What are the regulatory requirements for change control.
  • What is the current Process Development Strategy in Bio/Pharmaceutical industry and how change control is applied to different phase of drug development and manufacturing.
  • How to characterize process and define critical process parameters.
  • What kind of technology transfer strategies are applicable for Bio/Pharmaceutical industry.
  • Equipment and process qualification and validation as a final step of equipment change control.
  • Practical examples of equipment and process changes.

Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Pharmaceutical, Biologics, Medical Device, and Diagnostic fields. The employees who will benefit include:
  • R&D and Analytical Scientists
  • Process Development Engineers
  • QA managers and personnel
  • Validation specialists
  • Consultants
  • Quality system auditors

Instructor Profile:
Vadim Klyushnichenko, (Ph.D.) is the President and Founder of Key Pharma Consulting, LLC.Dr.Klyushnichenko has over 15 years of experience in Bio/Pharmaceutical 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, 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.

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