The Center for Professional Innovation & Education, Costa Mesa, CA
February 12 & 13, 2009
Who Should Attend This regularly updated two-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control Laboratories. The course will also be of benefit to Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance.
Learning Objectives Upon completion of this course you will: - Be conversant in the specialized language of laboratory compliance
- Be very familiar with the CGMPs and other regulations as they impact QC labs
- Know the current compliance “hot spots” that FDA and other regulatory authorities look for when inspecting QC labs
- Understand how to effectively deal with laboratory deviations and OOS results
- Know how to properly and efficiently qualify laboratory equipment
- Understand how to properly prepare your QC lab for audits and inspections
Course Description
This course is intended to give participants a thorough grounding in and practical understanding of Current Good Manufacturing Practices and other regulations in force in Quality Control laboratories. This course will also provide participants with an understanding of how to effectively handle out-of-specification results, laboratory equipment qualification, and many other topics essential to QC lab compliance. Additional benefits of this class include: - All participants receive a Resource CD with: a Reference List, 483s, Key Guidance Documents, and more
- Learn not just from the director, but tap into the knowledge of your peers: Participants who choose to will have the opportunity to anonymously submit their top CGMP challenges, problems, and issues for classroom discussion
- Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 15 years of industry experience, over 8 years of consulting experience, and over 10 years of experience directing CGMP training courses
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