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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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April 10, 2012 |
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CfPA - The Center for Professional Advancement, New Brunswick, NJ
August 9-10, 2012
Who Should Attend
This intensive two day course will benefit anyone involved in the pharmaceutical, biotechnology and medical device industries. It will be especially valuable to professionals involved in:
• Quality Control
• Quality Assurance
• Production
• Validation
• Engineering
• Audit
• Documentation
• Training
• Technical Support
• Maintenance Description
The FDA Agency investigations and audits of the regulated industries have spent much of their recent focus in the area of Data Integrity and the possible falsification of documents and the improper recording of significant data. Such Data Integrity Issues have been highlighted lately in 484's, warning letters, and consent decrees.
This intensive two-day course will help professionals in the FDA regulated industries with steps on how to avoid such common mistakes. The course will include the investigator’s perspective and will teach tactics to successful internal audit procedures to keep your company compliant. Numerous case studies involving both deliberate falsification and improper data recording that SUGGESTS falsification will be included.
The course will delve into concerns such as how to prevent data integrity problems, how to detect them and how to insure that they don't occur in the first place. The proper corrective actions, should Date Integrity Issues be detected, will also be addressed.
The course offers an interactive, open exchange environment. Participants are encouraged to bring their Data Integrity Issues to the course for discussion.
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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 Marshall; President, William G. Marshall and Associates
William G. Marshall is President of William G. Marshall and Associates. He has nearly forty 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
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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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