Webinar- GLP Amendments, Deviations and Unforeseen Circumstances: The Good, The Bad and The Ugly

RECORDING

Recorded: Thursday, September 17th, 2009

11:00 a.m. EST-12:00 noon -Eastern Standard Time-United States

INSTRUCTOR: Celeste Rose, RQAP-GLP, President/GLP Subject Matter Expert, RoseTECH Consulting, Inc.

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Webinar Content

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!

QUESTIONS AND ANSWERS

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

In this webinar, you will review or learn the following:

➢Basic GLP requirements pertaining to amendment, deviations and events

➢GLP roles and responsibilities

➢How to indentify and raise awareness of when deviations occur

➢Effective documentation of amendments, deviations and events

➢How to prevent, minimize and prepare for deviations

➢Real-life examples and resolutions

➢How to objectively address excursions and remove the stigma barriers.

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, has a bachelor’s degree in Chemistry and is certified by the Society of Quality Assurance (SQA) as a GLP Registered Quality Assurance Professional (RQAP-GLP). Ms. Rose has 25 years GLP experience and 10 years experience as a Study Director. She has a broad base of expertise in EPA, FDA and OECD Good Laboratory Practice, 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.

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