Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances

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 study and the quality and compliance of the GLP 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 deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations. Effective tactics to enhancing proper documentation and handling of deviations are discussed, as well as approaches to reducing the stigma of deviations so as to foster communication between study personnel and study director when deviations and unusual events do occur.

Areas Covered in the seminar:

• The importance of documentation of deviations and unexpected circumstances.
• Responsibilities of study director, principal investigator, QA and management.
• Deviations vs. amendments.
• How to identify a deviation or unexpected event.
• How to avoid unnecesary occurence of deviations.
• Taking the fear out of reporting deviations.
• Proper documentation of deviations and events.
• How to include deviations in the study report.

Who will benefit:

This Laboratory training will benefit all persons involved in the conduct, supervision, or monitoring of GLP studies or GLP support functions at test facilities including Pharmaceutical, Medical Device, Biologics, and Agricultural Chemical companies, as well as Contract Research Organizations (CROs), University, and Research testing laboratories. Persons who will benefit include:

• Test Facilty Management
• Study Directors and Principal Investigators
• GLP Personnel
• QA Managers and Auditors
• Document Control Coordinators
• Consultants

Instructor Profile

Celeste Rose,, RQAP-GLP, President of RoseTECH Consulting has over 25 years experience in Good Laboratory Practices (GLP) and is certified by the Society of Quality Assurance (SQA) as a Registered Quality Assurance Professional (RQAP). Her background includes laboratory experience “at-the-bench” with over 10 years experience as a Study Director conducting GLP studies in compliance with EPA and FDA regulations and guidelines and OECD GLP standards for submission to US and non-US regulatory agencies. She has been providing GLP consulting services to clients since 2002. Areas of expertise include training, GLP study audits and inspections, test facility inspections, CRO & subcontractor inspections, 3rd party independent audits, GLP start-up, quality system implementation, SOP writing and technical writing.

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