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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
April 8, 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 Medical Device Industry. 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
This training will also benefit suppliers of equipment and services to the medical device industry. Description
In recent years, the FDA has placed intense focus on Process Validation. This 90-minute, accredited training course will examine how we have reached the present validation environment and will give you a means for survival. It will provide a step-by-step guide to planning and preparing for process validation, and includes a discussion of how to write validation protocols, handle deviations, report validation results and “maintain the validated state.” The course provides a guide on how to manage the validation process efficiently and pragmatically. Further, this course provides “content understanding” so important for auditing validation activities as required in today's FDA regulated industry environment.
Module 1: Major revisions:
• How did we reach the present validation environment?
• Why do I need to validate processes?
• What is process validation?
• Does every process need to be validated?
Module 2: Post market surveillance:
• The Validation Master Plan
• Basics of validation
• What are all the letters in the alphabet soup?
• Protocol Basics and Content
Module 3: International harmonization:
• Handling Deviations
• Validation Reports
• Proper validation timing
• Maintaining the validated state
• Auditing Metrics for the Validation System
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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