GLP Deviations CONTENT Package

Package includes webinar recording with powerpoint presentation and bonus FAQ:

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

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

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

Click here to view complimentary excerpt

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

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!

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

Click here to view complimentary excerpt

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 Deviations CONTENT Package is only $129.00. Purchase now in the enKap store - click here