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Data Integrity Essentials

 
  November 15, 2017  
     
 
CfPA-The Center for Professional Advancement, Online Live
December 12, 2017 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

Course 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 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.

Can't Make this LIVE Webinar? 
Simply select the On Demand option when registering and we will send you the link to view the recorded version.

This course will be available On Demand: December 13, 2017
 
 
Organized by: CfPA-The Center for 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. 

 

Venue Information

 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: jmorbit@cfpa.com
 
   
 
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