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OtherPDA Paper

PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections

Deborah M. Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant and Denyse Baker
PDA Journal of Pharmaceutical Science and Technology February 2018, pdajpst.2018.008573; DOI: https://doi.org/10.5731/pdajpst.2018.008573
Deborah M. Autor
1 Mylan;
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  • For correspondence: debautor1@gmail.com
Zena Kaufman
2 Roivant Pharmaceuticals;
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Ron Tetzlaff
3 PAREXEL International;
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Maryann Gribbin
4 Faith and Royale Consultants;
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Madlene Dole
5 Novartis;
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Derek Glover
1 Mylan;
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Brad Mercer
6 Avantor Inc.;
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Doreen Newhouse
7 Bridge Associates International LLC;
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Jackie Veivia-Panter
8 Celgene;
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Anil Sawant
9 Merck;
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Denyse Baker
10 PDA
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Abstract

PDA has identified eleven current questions related to data management and control that have been frequently cited in FDA Inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices.

  • Best Practices
  • Data Integrity
  • Document Control
  • Document Management
  • Inspections
  • Received January 15, 2018.
  • Accepted January 21, 2018.
  • Copyright © 2018, Parenteral Drug Association
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deborah M. Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA Journal of Pharmaceutical Science and Technology Feb 2018, pdajpst.2018.008573; DOI: 10.5731/pdajpst.2018.008573

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PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deborah M. Autor, Zena Kaufman, Ron Tetzlaff, Maryann Gribbin, Madlene Dole, Derek Glover, Brad Mercer, Doreen Newhouse, Jackie Veivia-Panter, Anil Sawant, Denyse Baker
PDA Journal of Pharmaceutical Science and Technology Feb 2018, pdajpst.2018.008573; DOI: 10.5731/pdajpst.2018.008573
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Keywords

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  • Data Integrity
  • Document Control
  • Document Management
  • Inspections

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