Workshops
Advances in Sterile products technologies
CHAIR: Dr. Mathew Cherian (USA)
CO-CHAIR: Dr. Fars Alanazi (KSA)
Workshop Agenda
February 7th 2012
| 8:30—9:15 | 7:30—8:30 Registration/Sign-up |
| 8:30—9:30 | Introduction to the World of Sterile Products Eng. M. Sihra (USA) |
| 9:30—10:30 | Fundamentals of Formulating Sterile Dosage Forms Dr. Mathew Cherian (USA) |
| 10:30—11:00 | Coffee Break |
| 11:00—12:00 | Pharmaceutical Water & Steam Systems Dr. Paolo Curto (ITALY) |
| 12:00—1:00 | Sterile Dispersed Dosage Forms Dr. Mathew Cherian (USA) |
| 1:00—2:00 | Lunch |
| 2:00—3:00 | Emulsion Technology Dr. Mathew Cherian (USA) |
| 3:00—3:30 | Coffee Break |
| 3:30—5:00 | Sterilized Production: Process Improvement Using an Integrated Washing Sterilization Autoclave Dr. Paolo Pallado (ITALY) New Frontiers in Equipment Cleaning & Sterilization: Trends & Technologies Dr. Paolo Pallado (ITALY) |
February 8th, 2012
| 8:30—9:30 | Processing Disposable Syringes in Nests Mr. Otto Feil (GERMANY) |
| 9:30—10:30 | Proteins, Peptides and Monoclonal Antibodies Dr. Mathew Cherian (USA) |
| 10:30—11:00 | Coffee Break |
| 11:00—1:00 | Novel Processes for the Production of Recombinant Human Interferon Prof. Dr. Dahmani Fathallah (BAHRAIN) |
| 1:00—2:00 | Lunch |
| 2:00—2:45 | Quality Systems and Regulatory Guidance for Sterile Products Dr. Michael J. Miller (USA) |
| 2:45—3:30 | Environmental Monitoring: Current Perspectives and New Technologies Dr. Michael J. Miller (USA) |
| 3:30—4:00 | Coffee Break |
| 4:00—5:00 | Sterile Facility Design Fundamentals and Utilities for Sterile Facilities Eng. M. Sihra (USA) |
February 9th, 2012
| 8:30—9:30 | Isolator Technology & New Developments Dr. Paul Ruffieux (SWITZERLAND) |
| 9:30—10:30 | Analytical Techniques Dr. Mathew Cherian (USA) |
| 10:30—11:00 | Coffee Break |
| 11:00—12:00 | Rapid Microbiological Methods: PAT and Microbiology for Sterile Product Testing and Release Dr. Michael J. Miller (USA) |
| 12:00—1:00 | Lyophilization |
| 1:00—2:00 | Lunch |
| 2:00—3:30 | Cost Comparisons Between Sterile/Aseptic Production in Clean Room/RABS and with Isolation Technology Dr. Paul Ruffieux (SWITZERLAND) |
| 3:30—4:00 | Coffee Break |
| 4:00—5:00 | Sterile Process Overview Dr. Michael J. Miller & Eng. Sihra (USA) |
Chairs and Speakers
Dr. Mathew Cherian is the Research Director at Baxter, USA. During his 25 year career, he has been involved in formulation development, analytical development, process development and scale up, and sterile product manufacturing at Baxter, Fujisawa, Pharmacia and Pfizer. His expertise includes development of sterile dispersed dosage forms. He is a member of the EX Co of the FIP-Industrial Pharmacy Section.
Dr. Fars Kaed Alanazi is Vice President Assistant for Knowledge Exchange & Technology transfer and Associate Professor of Pharmaceutics King Saud University. Dr. Fars is Director of Al-Kayyali Chair for Pharmaceutical Industry, Member of Executive committee, Center of Excellence in Biotechnology Research, KSU and Director of Student Admission Assisting Office, United States Scholarship Project, Ministry of Higher Education Riyadh, Saudi Arabia.
Engineer Manmohan Sihra, M.S. Industrial Engineering, has over 30 years of experience in sterile pharmaceutical industry in engineering and operations. During his career he has held progressively important and responsible positions at Baxter, Fujisawa (now Astellas), Gensia, B. Braun and lately Director of Aseptic Process Design, Global Engineering at Bristol Myers Squibb. Manmohan’s is world expert in the areas of sterile processing, aseptic technology, facility design and sterile operations.
Dr. Paolo Curto, Ph. D. is Managing Director of DOC; a Company specialized in Validation & cGMP consulting for the Italian and International Pharmaceutical Industry. He has 24 years of international industrial experiences, working in Pharmaceutical Manufacturing Companies, US-FDA approved, as Engineering & Validation Director. He is also a Certified Trainer of Regulatory Authorities in Europe and China.
Dr. Paolo Pallado graduated in Chemical Engineering in 1989, he achieved a Ph. D. in Chemical Engineering in 1993 and a Post Doc ChE in 1995. After having improved his professional experience in several industrial fields, he joined Fedegari in 1999 for developing innovative technologies and processes for washing, sterilization, and decontamination.
Mr. Otto Feil is a project manager at Bausch + Ströbel with approximately 30 years of experience in special processing machines for the pharmaceutical, cosmetic, chemical and similar industries. He is responsible for the sales markets in Africa, Australia, Middle East, India, Greece and Benelux countries where he successfully realized complete processing and packaging line projects.
Prof. Dr. Mohamed Dahmani Fathallah is the Chairman and Director of the Biotechnology program at the Arabian Gulf University, in Manama. He is an International Expert in Technology Education & Transfer Strategies in the biomedical field. He is the former CSO of Jeddah-Biocity Inc. and CEO of Rethab-Biotech Co. He holds five international patents for the development of four biopharmaceutical products. He authored three books and published several papers in the topic.
Dr. Michael J. Miller is President, Microbiology Consultants, LLC, in Tampa, Florida. Over the past 22 years, he has held numerous R&D,manufacturing, quality and business development leadership roles at Johnson & Johnson, Eli Lilly and Company and Bausch & Lomb. He has published more than 100 book chapters, articles and scientific presentations; and has received many awards including the Parenteral Drug Association Distinguished Service Award. He is adjunct professor at Georgia State University, and is the Editor of the Encyclopedia of Rapid Microbiological Methods.
Dr. Paul Ruffieux is Vice President and a board member at SKAN AG, Switzerland. He holds a Ph.D. in Pharmaceutical Technology from the University of Basel and has an extensive experience in the Pharmaceutical Industry over 25 years in operations for solid and sterile forms in different pharmaceutical companies. He is an expert in isolation technology and played a key role in the design and building of sterile facilities.
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