GMP Laboratory Controls Professional Certification

Register for CfPA's GMP Laboratory Controls Professional Certification
Register for CfPA's GMP Laboratory Controls Professional Certification

What Is a GMP Laboratory Control Certification and Why Do I Need It?

"The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control," the FDA states in its own Guide to Inspecting Quality Control Laboratories. The quality control laboratory and product testing are covered by a significant portion of the CGMP regulations (21 CFR 211). " Accurate, reliable, and meaningful laboratory data is critical for the approval and use of raw materials, the release of commercial batches, and the support of a given product's shelf life."

Given the large number of FDA observations cited each year for laboratory operations, it is clear that industry is not fully complying with FDA requirements. Such flaws in laboratory operations can and do result in recalled batches, court injunctions, and even the forced discontinuation of commercial operations, all of which have a negative impact on company profitability. FDA-regulated organizations must ensure that their laboratories are fully compliant with GMPs.

Our GMP Laboratory Control Certification program teaches you the fundamental concepts and tools that a GMP Laboratory Control Professional must know. Its goal is to give rules, tools, and methods for managing GMP labs in a way that is effective and legal. This GMP Laboratory Control Certification Program gives professionals like you the training and skill development they need to earn their certificate of completion.

Hear from David Wiggins, CfPA Course Instructor/Analytical Consultant and prior Sr. Associate Director of Analytical Development for Bayer Consumer Care, on the importance of achieving your GMP Laboratory Control Certification and the benefit of our program.

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 the following areas:

  • Research and Development
  • Quality Control
  • Quality Assurance
  • Technical Operations
  • Contract Laboratories
  • Those who work in regulatory affairs or are in charge of reviewing or auditing lab data and reports should also think about how valuable this comprehensive certification is for their jobs.

    Why become a Certified GMP Laboratory Control Professional?

    As a Certified GMP Laboratory Control Professional, you will receive training in effective and compliant laboratory control operations, as well as techniques, tools, and FDA regulatory knowledge sufficient to avoid noncompliance issues.

    The Certified GMP Laboratory Control Professional 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.

  • In addition, the Certified GMP Laboratory Control Professional will know how to cut costs and save time.

    How to Earn Your GMP Laboratory Control Certification?
    Becoming a candidate is easy.

    Enroll: Register for the complete 10 course program. You will receive an email with instructions on accessing the courses.

    Learn: Attend each of the 10 courses and successfully pass the self-assessment with a score of 80% or higher.

    Earn: Once you have fulfilled all the program requirements, you will receive a certificate recognizing your achievement.

    Register for CfPA's GMP Laboratory Controls Professional Certification

    What courses are included in the GMP Laboratory Control Professional 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

  • Want to certify a group? Learn more about team certification by chatting with us now.