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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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Article Information

pdajpst.2018.008573
DOI 
https://doi.org/10.5731/pdajpst.2018.008573
PubMed 
29444995

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received January 15, 2018
  • Accepted January 21, 2018
  • Published online February 14, 2018.

Article Versions

  • You are currently viewing a previous version of this article (February 14, 2018 - 18:16).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2018, Parenteral Drug Association

Author Information

  1. Deborah M. Autor1,11 (debautor1{at}gmail.com),
  2. Zena Kaufman2,
  3. Ron Tetzlaff3,
  4. Maryann Gribbin4,
  5. Madlene Dole5,
  6. Derek Glover1,
  7. Brad Mercer6,
  8. Doreen Newhouse7,
  9. Jackie Veivia-Panter8,
  10. Anil Sawant9 and
  11. Denyse Baker10
  1. 1 Mylan;
  2. 2 Roivant Pharmaceuticals;
  3. 3 PAREXEL International;
  4. 4 Faith and Royale Consultants;
  5. 5 Novartis;
  6. 6 Avantor Inc.;
  7. 7 Bridge Associates International LLC;
  8. 8 Celgene;
  9. 9 Merck;
  10. 10 PDA
  1. ↵* Corresponding author; email: debautor1{at}gmail.com

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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

  • Best Practices
  • Data Integrity
  • Document Control
  • Document Management
  • Inspections

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