GLP Compliance Audits: What to look out for at a New Nonclinical CRO

Why Should You Attend:

GLP Compliance is a crucial element of any nonclinical safety studies performed in support of an IND, IDE or product licensure. Prior to placing or initiating any key IND enabling toxicology or safety studies at a new laboratory, it is critical to evaluate the facility's overall level of GLP readiness. This webinar will discus how to perform pre-study GLP compliance audits and what to look for at candidate nonclinical CRO’s. The importance of SOPs, test material handling and accurate data capture will be discussed. Also, what should you look for in a sharp QA unit, and does the facility police itself sufficiently? Finally how compliant are the CRO's protocols and reports and what should you look out for once the study or studies have begun? Particularly for employees and management of small biotech organizations, this talk will stress the key elements of GLP oversight necessary for successful execution of nonclinical safety studies.

Areas Covered in the seminar:

• When and why should I perform a GLP audit of nonclinical CROs?
• Asking the right questions.
• What to watch out for on the facility tour.
• The Importance of the QA Unit.
• What you can learn from an organization from its SOPs.
• Documentation you must review on an audit.
• The importance of having an audit agenda.
• In-Phase GLP Study monitoring - What to do once the study starts!

Who will benefit:

This webinar will be valuable for any member of a pharmaceutical or biotechnology organization charged with placing or monitoring nonclinical GLP safety studies. From CEOs of small biotech companies to internal QA groups to nonclinical development staff, this talk will provide the basics to performing brief, yet comprehensive GLP audits of nonclinical laboratories.Those who might benefit include:

• Senior management of small to mid-size biotech organizations
• Internal QA professionals at sponsor organizations
• Bench Scientists moving into GLP regulated studies
• Toxicologists at Nonclinical CROs

Instructor Profile:

David Pepperl, Ph.D., is a toxicologist with the Biologics Consulting Group, a consulting group specializing in the development and regulation of biologic products. David designs and develops nonclinical programs for small molecule and biologic products. He works closely with sponsors and the FDA to navigate regulatory paths for cell and gene therapy products, and his recent experience includes early stage preclinical development planning and nonclinical study design, regulatory toxicology, GLP toxicology study oversight and monitoring, as well as both pre-IND and IND review and preparation.

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