GCP Lab focused

Edward 'O' Connor

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This training will discuss the development and application of Good Clinical Laboratory Procedure within the Bioanalytical Lab. Participants will learn how and why certain element of the protocol and informed consent need to be observed to apply regulatory mandates and about the repercussions of unsigned informed consent, failure to follow GCP,  ownership issues and sample disposition on study, sponsor and the bioanalytical lab.

Why Should You Attend:

This webinar will provide an overview of the concepts of GCP including history and evolution. The opportunity for failure and the consequences will be discussed.  The importance of the designand application of the informed consent form and informed sample ownership/disposition will be illustrated .as will the role of the bioanalytical labs in reviewing these documents as well as suggesting edits/amendments to clinical trial sponsors to ensure compliance and success.  Guidance fromof regulatory agencies including the Food and Drug Administration (FDA), the International Conference on Harmonization (ICH), and the Committee for Medicinal Products for Human Use (CHMP)/ the European Medicines Agency will be covered.

This presentation examine GCP during all phases of the product cycle, the regulatory mandates, risk-management strategy and potential consequences for failures in inadequate assessment, and case studies, 483 and warning letters of infractions.

In conclusion, this webinar will educate the participant on central components of GCP in general and as they relate specifically to the bioanalytical laboratory.

Areas Covered in the Seminar:

  • Overview, History and evolution of the GCP
  • Specific guidance offered by the FDA
  • Responsibilities to maintain GCP
  • Components of the informed consent both for participation and sample disposition
  • HIPAA and GDPR
  • Risk management strategy.

Who Will Benefit:

  • Executive management
  • R&D investigators
  • Product development
  • Pre-clinical and clinical
  • Regulatory affairs
  • QA/ QC
  • Marketing
  • Consultants
  • Training
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Edward 'O' Connor,

Ed'O'Connor is currently senior consultant for Aegis Bio consulting. He has over 20 years in regulated bioanalysis serving in Director or manager level roles in Biotech at Alexion, Elusys, Biogen and Medimmune and At CROs including Matrix, Tandem, Therimmune and Covance. He has a PhD in Zoology from UMass Amherst and a BS degree from Texas A&M Commerce. His post-doctoral training focused on the neuroendocrine system in health and disease. Edward'O'Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non-clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research as well as Biotech's MedImmune, Biogen and Elusys.

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