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The Center for Professional Advancement, Free Webinar
November 18, 2009 with Two Opportunities to View: 10:00 a.m. or 2:00 p.m. (ET)
Who Should Attend
This FREE webinar will benefit anyone involved in the pharmaceutical and medical device industries, including those involved in: Q.C., Q.A., Production, Validation, Engineering, Audit, Documentation, Training, Technical Support, Maintenance, and Development. Description
Data Integrity has recently become a focal point in FDA Agency investigations and audits due to a recent history of numerous incidents where companies have been cited for the manner they treated the recording of data. In these cases, the manner in which events were handled led the investigator to believe that FALSIFICATION of data may have occurred. Often the parties involved were not aware at the time of the weaknesses of their actions. Several Data Integrity case studies involving both Deliberate Falsification and improper data recording that SUGGESTS Falsification will be discussed. This FREE, 60-minute presentation will include audit tips on how to find these issues, as well as how to avoid common pitfalls. What to do when Data Integrity issues are found will also be addressed.
Our FREE Webinar will answer these questions:
• What is a Data Integrity problem?
• What should be done if we find a Data Integrity issue?
• Why do Data Integrity issues occur?
• What next?
• How can we spot a Data Integrity issue?
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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William G. Marshall is 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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salbers@cfpa.com
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