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

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;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: debautor1@gmail.com

Zena Kaufman

2 Roivant Pharmaceuticals;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Ron Tetzlaff

3 PAREXEL International;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Maryann Gribbin

4 Faith and Royale Consultants;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Madlene Dole

5 Novartis;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Derek Glover

1 Mylan;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Brad Mercer

6 Avantor Inc.;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Doreen Newhouse

7 Bridge Associates International LLC;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Jackie Veivia-Panter

8 Celgene;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Anil Sawant

9 Merck;

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Denyse Baker

10 PDA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Article
References
Info & Metrics
PDF

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

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

Cited By...

Citations
Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 74, Issue 4

July/August 2020

Table of Contents
Index by Author
Complete Issue (PDF)

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 3 + 0 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

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

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

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

Share This Article: