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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
April 1, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training course is intended for managers, supervisors, engineers, chemists, scientists, technicians and formulators working within the Pharmaceutical, and related industries. It will also be valuable to documentation specialists, auditors and those in regulatory affairs. Personnel from the following departments will find the course beneficial:
• Research and Development
• Quality Assurance and Control
• Manufacturing/Operations
• Facilities
• Finance
• IT
• Audit
• Training
• Technical Support Description
Environmental Monitoring in Non-Sterile product manufacturing has become a current practice that encompasses temperature, relative humidity, non-viable (and in some cases, viable) particle counts, room classifications, pressure differentials and other environmental parameters. This 90-minute accredited training course will discuss monitoring procedures, frequencies, alert and action limits that are needed to assure compliance.
Module 1:
• What areas need monitoring in the non-sterile product
manufacturing facility?
• Which parameters need to be monitored in the various
areas?
• How is this monitoring typically carried out?
Module 2:
• What are typical monitoring frequencies?
• Setting alert and action limits
• Avoiding pressure differential pitfalls
Module 3:
• Understanding the impact of manufacturing personnel
on the environment and the need for training
• Auditing the environmental program
Question and Answer Session
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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William G. Marshall, President of William G. Marshall and Associates; Consultant to the worldwide drug and device industry as well as to the FDA and worldwide lecturer in GMP related issues.
William G. Marshall is President of William G. Marshall and Associates. He has over twenty years experience in the Pharmaceutical and Medical Device Manufacturing Environment. Mr. Marshall has held Director level and Chief Operating Officer positions with large multinational pharmaceutical corporations as well as start-up ventures. He has been the Director of a major reference laboratory, and has been active in clean room design and validation. In the last five years, he has acted as a third party in several consent decrees.
Mr. Marshall is currently a consultant to the worldwide drug and device industry as well as to the FDA. He lectures worldwide in GMP related issues including Clean Room Technology and Sterilization. In the past 18 months, he has been involved in 10 Pre-Approval Inspections that include the first aseptic processed injectables from India, the first ever drugs from Turkey, and APIs from China, that were all approved for introduction to the US market. He has a Master's Degree in Biology from Georgetown University, Washington, DC.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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