Research ArticlePDA Papers

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

Deb 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 May 2018, 72 (3) 332-337; DOI: https://doi.org/10.5731/pdajpst.2018.008573

Article Information

vol. 72 no. 3 332-337
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 
  • Published online June 18, 2018.

Article Versions

Copyright & Usage 
© PDA, Inc. 2018

Author Information

  1. Deb Autor*,
  2. Zena Kaufman,
  3. Ron Tetzlaff,
  4. Maryann Gribbin,
  5. Madlene Dole,
  6. Derek Glover,
  7. Brad Mercer,
  8. Doreen Newhouse,
  9. Jackie Veivia-Panter,
  10. Anil Sawant and
  11. Denyse Baker
  1. Mylan
  2. ZGK Quality Consulting
  3. PAREXEL International
  4. Faith and Royale Consultants
  5. Novartis
  6. Mylan
  7. Avantor Inc.
  8. Bridge Associates International LLC
  9. Celgene
  10. Merck
  11. PDA
  1. ↵* Corresponding Author: Deb Autor, Head of Strategic Global Quality and Regulatory Policy, Mylan. Telephone: 202-507-5345; E-mail deborah.autor{at}mylan.com
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PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections
Deb 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 May 2018, 72 (3) 332-337; DOI: 10.5731/pdajpst.2018.008573
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