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

Instructor: Celeste Rose
Product ID: 701246
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2009

Training CD / USB Drive

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Read Frequently Asked Questions

This Good Laboratory Practice training defines deviations and unexpected events, the similarities and differences between deviations and amendments, and will present strategies to minimize the occurrence of unnecessary deviations.

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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