GMP Laboratory Control Professionals Certification Program Training Course
In their own Guide to Inspecting Quality Control Laboratories, the FDA states: The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Accurate, reliable, and meaningful laboratory data is critical to the approval and use of raw materials, release of commercial batches, and support of the shelf life for a given product.
Given the significant number of FDA observations cited each year related to Laboratory Operations, it is obvious that industry is not fully satisfying FDA requirements. Such deficiencies in the laboratory operations can and does lead to recalled batches, court injunctions and even forced discontinuance of commercial operations thus negatively impacting company profitability. FDA regulated organizations are obligated to ensure that their laboratory operates fully in compliance with GMPs.
Cobblestone’s 10-part GMP Laboratory Control Certification program provides the key principles and tools required to become a GMP Laboratory Control Professional. It is designed to provide rules, tools and techniques for effective and compliant management of a GMP laboratory. This GMP Laboratory Control Certification Program offers professionals the proper training and skill development needed to attain their certificate of accomplishment.
Upon completion of this Certification, you will be able to:
- Operate as a laboratory analyst in full GMP compliance.
- Plan and manage laboratory control operations.
- Comply with all applicable regulatory requirements.
- Train and mentor staff. Develop SOPs and tools.
- Represent the organization in audits and regulatory investigations.
- Interact with management, regulators, and auditors.
FROM THE ATTENDEES:
“Laura provided a wealth of knowledge, and her thorough industry experience really shined through with the presentation of information. Though it was a lot of content, she broke it up in a very digestible manner. The course definitely enhanced my understanding of CAPAs & the CAPA process, which will improve my ability to contribute to conversations and communicate effectively with industry experts.” – Life Sciences Recruiter at Vi-Leon
COURSE OUTLINE
Module 1:
- CAPA and Regulatory Requirements for Pharmaceuticals and Medical Device
- Correction and Preventive Actions and their meaning
- Writing Effective CAPA Plans and implementation
Module 2:
- CAPA Reviews and Closure
- CAPA Effectiveness and follow-up
- Trends and insights