The Center for Professional Innovation & Education, Dublin, Ireland
April 22 & 23, 2010
Who Should Attend This 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 Analytical Laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This course will also provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations, Corrective and Preventive Actions.
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
- Understand the what, how and why of laboratory equipment qualification and methods validations
- Understand how to properly prepare your QC lab for audits and inspections
Course Description
This course is intended to give participants a thorough overview and practical understanding of Current Good Manufacturing Practices for laboratory compliance including: - General requirements for design and construction of analytical laboratories
- Calibration and Qualification of instrumentation and equipment
- Documentation, records-keeping and change control
- Management of reagents, test solutions and reference standards
- Personnel development and training
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