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CfPA-The Center for Professional Advancement, 60 Minute Accredited Online Training
November 20, 2014 at 11:00 a.m.–12:00 p.m. (ET)
Who Should Attend
This online training will benefit professionals in the pharmaceutical, medical device and related allied industries.
It will be especially valuable to those involved in
• QA/QC Production
• Validation
• Engineering
• Audit
• Documentation
• Training
• Technical Support
• Maintenance
• Development
Description
This course will be available On Demand: November 21, 2014
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 investigators 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 60-minute, accredited training presentation will include audit tips on how to find these issues, as well as how to avoid common pitfalls. In addition, the proper steps to take should a Data Integrity issue arise will be addressed through lecture and case study examples.
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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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