GMP Laboratory Controls Professional Certification
What Is the GMP Laboratory Control Certification
and Why Is It Needed?
In their own Guide to inspecting Quality Control Laboratories, 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.
高h文 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.
CfPA’s GMP Laboratory Control Certification program provides the key principals 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.
Who Will Benefit by the GMP Laboratory Control Certification?
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 product 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.
Who Is a Certified GMP Laboratory Control Professional
The Certified GMP Laboratory Control Professional is an individual trained in effective and compliant laboratory control operations; exhibiting the techniques, tools and knowledge of FDA regulations sufficient to avoid non-compliance issues. The Certified GMP Laboratory Control Professional will be able to:
高h文 In addition, the Certified GMP Laboratory Control Professional will know how to cut costs and save time.
Benefits to the Candidate
The GMP Laboratory Control Professional Certification recognizes that the Candidate has completed and demonstrated proficiency in each of the the required series of online courses, The distinction of a GMP Laboratory Control Trained Professional can differentiate the candidate from others in their industry.
The GMP Laboratory Control Professional Certification Program consists of 10 intensive, 90-minute courses, a total of 15 contact training hours. Candidates must complete and score at least 80% in the Learning Assessment* for each course.
*Learning Assessment is a means of testing that will be administered as part of each course. This resource will be used to verify that mastery of the subject has been achieved.
How To Become A GMP Laboratory Control Professional
Becoming a Candidate for a CfPA Online Certification is easy. There are no additional fees beyond the standard course tuition.
Simply sign up for one at a time or all the complete certification program Pre-enrollment savings when you enroll in the entire 10 course program.
Courses included in the 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
These courses are available from time to time in live format and are subsequently available on demand for your convenience. Check the CfPA website for the next live presentation or register at any time for the on demand course.
Courses within this or any CfPA Certification Program may be taken individually for further career advancement