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

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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