Webinars>>​FDA Regulations
GLP Simplified: Meeting FDA Requirements without Breaking the Bank

This course is intended for those interested in understanding the Good Laboratory Practices (GLP) requirements for facilities engaged in toxicology and product safety testing in animals and cell culture systems. The course is designed to help you better understand the Good Laboratory Practices (GLP) requirements set forth by the FDA. These principles also apply to testing labs involved in clinical sample analysis. The OECD and FDA requirements for GLP will be discussed along with practical tips for their application in all kinds of organizations. Best practices for SOPs, documentation, training, facility design, equipment set-up, validation and maintenance, and study reports will be covered in the session.
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The responsibilities and functions of management including the Study Director, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. The presenter will use case studies from his extensive experience to emphasize optimum requirements to meet FDA’s requirements rapidly, efficiently and economically. 
Why should you attend:

This seminar will provide details of the regulations and practical tips to meeting regulatory requirements in diverse setting with limited resources. Attendees will be provided with list of SOPs and best practices, and sources to get additional information. If you are planning to test drugs or biological substances, this seminar will give you useful tips from the presenter’s extensive experience about FDA’s expectations from GLP studies. This seminar will discuss the current rules and practical tips for being compliant with the FDA expectations. This seminar will act as a great building block to get you started on GLP requirements and provide an excellent base for additional training, as needed. 
Areas Covered in the Session:
  • Principles of GLP as defined by FDA and OECD
  • FDA guidance documents for preclinical and sample testing
  • FDA’s enforcement of GLP compliant organizations
  • Difference between GLP and non-GLP studies
  • Difference between CLIA and GCLP
  • SOPs, documents, reports and other documents in GLP labs
  • Facility, personnel, and business aspects of GLP  
Who will benefit:
  • Drug discovery scientists
  • Safety pharmacologists
  • Toxicologists
  • Scientists in lead optimization
  • Project Managers
  • Regulatory Vice Presidents, Directors and Managers
  • Lab testing professionals
  • Compliance professionals
  • Auditors
  • Attorneys – In-house or Outside Counsel
Date: September 18, 2017
Time: 12 PM EST
Duration: 60 Minutes

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com