This Sterile manufacturing webinar will review the regulations of Good Manufacturing Practices for Bio/Pharmaceutical industry, design and construction features, including materials for construction and facility operational flow diagrams and layouts.
Aseptic processing plants are the most complex facilities to design, construct and operate within the pharmaceutical industry. Therefore, the design, utilization, and sanitization of a facility and equipment must be addressed to ensure minimum levels of contamination during processing of the product components by people. This presentation will review the regulations of Good Manufacturing Practices for Bio/Pharmaceutical industry, design and construction features, including materials for construction and facility operational flow diagrams and layouts. Particular attention is brought to clean room requirements, design and specifications, barrier and isolator technology, air filtration control, cleaning and sterilization. Several examples of facility layouts with different size and operational functions are presented for considerations.
Areas Covered in the seminar:
- Regulations of Good Manufacturing Practices for Bio/Pharmaceutical industry.
- Design and construction features, including materials for construction and facility operational flow diagrams and layouts.
- Clean room requirements, design and specifications.
- Barrier and isolator technology.
- Air filtration control, cleaning and sterilization.
- Examples of facility layouts with different size and operational functions.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to build, update or outsource facilities for Bio/Pharmaceutical manufacturing. The employees who will benefit include:
- R&D and Analytical Scientists
- Process Development Engineers
- QA managers and personnel
- Validation specialists
- Consultants
- Quality system auditors
- Financial specalists in Bio/Pharmaceutical industry
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.
