David E. Wiggins
Danielle DeLucy, M.S.
Charlie Neal
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:
Courses Included in this Certification:
Laboratory Controls Overview & Establishment of Specifications
Analytical Methods Validation – 21CFR211.165(e)
Stability Testing – 2 CFR 211.166 (a & b)
IQ, OQ and PQ for the Laboratory
Good Documentation Practices for Laboratory Records
How to Manage and Prepare for a Pre-Approval Inspections (PAI)
Managing Standard Operating Procedures (SOPs) in the FDA-Regulated Environment
Handling OOS Test Results and Completing Robust Investigations
Laboratory Controls: Anticipate the Systems-Based FDA Inspection
Data Integrity Practices for the Laboratory and Beyond
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The GMP Laboratory Control Certification will be valuable to all individuals working within or managing a GMP laboratory that supports either the R&D development of a new drug product or the testing and control of commercial drug products released to the market.
Obtaining the certification would be beneficial to professionals in:
Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such laboratory data and reports should likewise consider the value of this comprehensive certification in their positions.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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