Webinar Recording-GLP – Effective Documentation and Study Reconstructability

Instructor: Celeste A. Rose, RQAP-GLP; GLP Subject Matter Expert

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WEBINAR SUBJECT MATTER CONTENT

This webinar covers the gamut of the GLP study lifecycle and provides insight and recommendations on approaches to improve study documentation and reconstructability. A quality protocol sets the platform. Tactics for achieving effective documentation of raw data and study observations are discussed. Examples are presented of techniques to simplify data capture and ensure good documentation, as well as how to avoid poor documentation “pitfalls” and handle inconclusive and problematic results and conclusions.

Study reconstructability is more than just “good record keeping practices”. Reconstructability is a result of:

• A well-written protocol –flexible, yet detailed
• Proper documentation of amendments and deviations
• Good recordkeeping practices – recorded directly, promptly, and legibly with proper error correction and traceability
• Effective documentation and capturing important details
• Accurate raw data sufficiently detailed to allow reconstruction with similar results/conclusions
• Accurate, well-written, compliant report

Ten reasons why effective documentation and reconstructability are so important:

1. Scientific integrity depends on documentation integrity. Documentation must be recorded for the reader. (You already know what you did.)
2. Documentation and reconstructability is an indication of the Study Director’s control of the study.
3. Documentation must support study results and conclusions.
4. Good documentation facilitates the generation of the study report and can save time and $$.
5. Good study reconstructability can expedite QA review.
6. GLP studies have a life after study conduct. Archival of a completed study is not the end of the road.
7. Study reconstructability may be needed to support future study decisions.
8. When the FDA or EPA arrives at your site, GLP study file documentation must be clear enough to allow for reconstructability of the study.
9. If reconstructability is difficult or impossible, study integrity is impacted, compliance is jeopardized, and the validity of the study may be in question.

10. GLP study reconstructability is a regulatory requirement!

QUESTION AND ANSWER SESSION

There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor Celeste Rose will provide an email response after the webinar concludes.

WHAT ATTENDEES WILL LEARN IN THIS WEBINAR

• “WHY” GLP requires good documentation
• Scientific integrity depends on documentation integrity
• Documentation is not for the writer’s sake, but for the “reader”
• Keys to documenting a reconstructable study
• How to avoid “pitfalls” to reconstructability

WHO SHOULD ATTEND

This webinar is an ideal presentation for those individuals in your organization involved in the following functions:

• Study Director
• Principal Investigators/Contributing Scientists
• Study Personnel
• Test Facility Management/Test Site Management
• Quality Assurance
• Document Control
• Sponsors

ABOUT YOUR INSTRUCTOR

Celeste A. Rose, RQAP-GLP, President of RoseTECH Consulting

Certified by the Society of Quality Assurance (SQA) as a GLP Registered Quality Assurance Professional (RQAP-GLP) with 25 years GLP experience and 10 year experience as a Study Director. She has a broad base of expertise in EPA, FDA, and OECD Good Laboratory Practices, including study direction/study conduct, protocol/report writing and documentation, technical writing, SOPs writing and review, archiving procedures, data, in-study and facility audits, and regulatory and technical training. Ms. Rose has over seven years experience as President of RoseTECH Consulting, Inc. as a consultant in the areas of GLP and Quality Assurance. She has a bachelor’s degree in Chemistry.

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