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ISPE Baseline Guide 5 C&Q, Quality Control, Validation

True Copy Verification: Getting it Right

True Copy verification is a required component of any paperless validation system, critical to maintaining compliance and GxP standards while removing the cost and inefficiency of paper. It’s not so simple as scanning a document however. Hear from industry experts from the ISPE Paperless Validation Subcommittee on how to get True Copy right, and why they’re important to your business. 

Thao Phan of Eli Lilly, Dave O’Connor of No deviation, and Mark Drinan of Takeda share their experiences and advice on how to ensure True Copy verification is streamlining your validation without expanding your risk. 

 

Attend and learn:

  • What is True Copy Verification
  • The correct application of second person verification in the true copy process 
  • How to compliantly destroy original copies after verification of true copy
  • The difference between Static and Dynamic Data 
  • Dynamic data requirements 

 

Presented by:

                                      

Thao Phan, Advisor, Engineering Technical Center, Eli Lilly & Co.

                                      

Dave O’Connor, C&Q Digital Transformation Manager, No deviation 

                                      

Mark Drinan, Small Molecule Operational Unit Lead CQV, Takeda 

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