GLP Documentation CONTENT Package

Package includes two webinar recordings with powerpoint presentations and bonus FAQ:

➢ 1.GLP – Effective Documentation and Study Reconstructability (One Hour Webinar Recording)

➢ 2.GLP – Effective Documentation and Study Reconstructability (PowerPoint Training Presentation)

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➢ 3.GLP Amendments, Deviations and Unforeseen Circumstances: The Good, The Bad and The Ugly (One Hour Webinar Recording)

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➢ 4.GLP Amendments, Deviations and Unforeseen Circumstances: The Good, The Bad and The Ugly (PowerPoint Training Presentation)

➢ 5. GLP Amendments and Deviations: Frequently Asked Questions and Answers (Bonus FAQ)

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1. and  2. GLP – Effective Documentation and Study Reconstructability (One Hour Webinar Recording & PowerPoint Training Presentation)

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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!

3. and 4. GLP Amendments, Deviations and Unforeseen Circumstances: The Good, The Bad and The Ugly (One Hour Webinar Recording & PowerPoint Training Presentation)

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All experimental data generated in a GLP study, including observations of unanticipated responses, are required to be accurately recorded and verified. Proper documentation of deviations and events is crucial to the reconstructability of a GLP study and the quality and compliance of the study report. Documentation of protocol and SOP deviations and unexpected events can be problematic if not handled properly, and can impact the integrity of the study. This session defines amendments, deviations and unforeseen circumstances, similarities and differences, and presents strategies for the prevention and/or minimization of the potential for the occurrence of unnecessary deviations, as well as proper documentation of the inevitable.

Effective tactics to enhancing proper GLP-compliant documentation and handling of deviations are discussed and includes approaches to reducing the stigma of deviations, so as to foster good communication between study personnel and study director when deviations and unusual events do occur.

➢GLP Studies – Welcome to the Real World!

➢Defining Amendment, Deviation and Unforeseen Circumstances

➢Ideal World vs. Real World – what can go wrong: Procedures, Test systems, Test articles, Equipment, Documentation, Schedules, Samples

➢Protocol Amendments: Intentional changes, Proper documentations, Requirements, Benefits – Use it as a “Tool”

➢ Deviations: Types of Deviations - protocol, SOP, test methods, regulations; How/when do they occur, Causes

➢ Unforeseen Circumstances: Recognizing when to document, When do they occur

➢Deviations and Unforeseen Circumstances: Proper documentation, Requirements, Benefits – Use it as a “Tool”

➢Documentation: What to write, When/how to document, Review and approval – what do the regulations require, Corrective actions, Assessment of impact on study integrity, Formats

➢Aspirations: Prevent the “avoidable” pitfalls, Minimize the “potential” for deviations, Prepare for the “inevitable unknown”

➢Plan for the Best/Prepare for the Worst: Well written procedures, Avoiding Pitfalls, Examples of Do’s and Don’ts, When All Else Fails – Document!

5.GLP Amendments and Deviations: Frequently Asked Questions and Answers (Bonus FAQ)

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Excursions from GLP procedures, such as protocols, standard operating procedures, and test methods, can be problematic and impact the integrity of the GLP study. Simple strategies can be easily implemented to avoid procedure pitfalls by preventing or minimizing the potential for excursions to occur in the first place. Because of the nature of GLP studies, procedural excursions inevitably do and will occur. When they do occur, proper documentation of amendments, deviations, unforeseen circumstances and unusual events are crucial to the reconstructibility of a GLP study and the quality and compliance of the study report. Responses to ten frequently-asked questions related to excursions which occur in the real world of GLP are presented.

GLP Documentation CONTENT Package is only 199.00