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

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 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).
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Author Information

Deborah M. Autor1,11 (debautor1{at}gmail.com),
Zena Kaufman2,
Ron Tetzlaff3,
Maryann Gribbin4,
Madlene Dole5,
Derek Glover1,
Brad Mercer6,
Doreen Newhouse7,
Jackie Veivia-Panter8,
Anil Sawant9 and
Denyse Baker10

¹ Mylan;
² Roivant Pharmaceuticals;
³ PAREXEL International;
⁴ Faith and Royale Consultants;
⁵ Novartis;
⁶ Avantor Inc.;
⁷ Bridge Associates International LLC;
⁸ Celgene;
⁹ Merck;
¹⁰ PDA

↵* Corresponding author; email: debautor1{at}gmail.com

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PDA Journal of Pharmaceutical Science and Technology

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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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