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Ensuring Data Integrity: A Multi-Disciplinary Approach

  October 30, 2017  
CfPA-The Center of Professional Advancement, Burlingame, CA
March 8, 2018

Who Should Attend?
This intensive one day course will benefit anyone involved in the pharmaceutical 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
  • Development

Course 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. In fact, numerous citations have been issued to companies for the manner in which they are or have been treating the recording of pertinent data. Although on many occasions, the personnel involved in these infractions are not aware of the shortcomings of their work, in some cases the FDA inspectors’ interpretation can lead to the belief that a Falsification of data may have occurred. This intensive one-day course will help professionals in the FDA regulated industries with steps on how to avoid such common mistakes.The course will include the investigators perspective and will teach tactics to successful internal audit procedures to keep your company compliant. What to do when Data Integrity issues are found will also be addressed. Several Data Integrity case studies involving both deliberate falsification and improper data recording that SUGGESTS Falsification will be discussed.
Organized by: CFPA-The Center of Professional Advancement
Invited Speakers:
   William Marshall, President, William G. Marshall and Associates

William G. Marshall is President of William G. Marshall and Associates. He has over forty years of 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.

Mr. Marshall’s training continues to receive CfPA’s most highly rated reviews. He liberally uses Case Studies from Warning Letters and Consent Decrees and his 40 plus years working in manufacturing and consulting in over 25 countries. Attendees are encouraged to question , debate , and share their own problems and successes. Mr. Marshall’s style of training is to keep the course very interactive. Attendees find his enthusiasm, knowledge, and experience, wrapped in a sense of humor, stimulating as well as informative.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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