The Leader in Quality Life Science Training

GMP Training for the QC Laboratory

  • Slide title

    "Dynamic presentation style kept my interest. Practical examples were really useful in making course material relevant. Length of course was good; not too long and not too condensed. Course material was well developed and nicely presented for attendees." 


    Diana B., QC Chemistry Manager, Allergan

  • Slide title

    "The instructor was extremely energetic and maintained focus of the entire group at all times. Never once did I look at my watch to see how much longer we had to go. He was extremely well versed in all areas and offered appropriate examples to drive home all key concepts."


    Lauren B., Project Manager, Chiron

  • Slide title

    "The material and speaker was great. I liked the examples that he used to convey the material. I appreciated allowing as many students' questions as he did. The recommendation given to read the secondary materials; such as website literature, court cases, and guidance documentation was very helpful. I would look for more classes to take from this course director and company again."


    Kristi C., Lab Technician

Course Director

Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

Quality Control Laboratory GMP Training Course Description

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
  • Have an understanding the what, how and why of laboratory equipment qualification and methods validation
  • Understand how to properly prepare your QC lab for audits and inspections

Who Should Attend

This 15 hour GMP training for QC laboratory course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control 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 and Corrective and Preventive Actions.

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  • Learning Objectives

    The Quality Control Laboratory GMP Training 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

  • Agenda

    Regulations – Guidances – Problems


    Session 1 – Introduction

    • Agencies and Guidance Documents
    • Overview of CFR Title 21, Parts 58, 210 and 211, an abbreviation and acronym primer 

    Session 2 – Title 21 Overview, Part 58, 210, 211

    • The FDA and History of GMPs

    Session 3 – Phases of Drug Development

    • Design of a Quality Control laboratory

    Session 4 – 21 CFR 211:  GMP for Human & Animal Drugs

    • Training Program
    • Subpart C: Buildings and Facilities
    • Part 211 Subpart D:  Equipment and Instrumentation
    • Subpart E: Control of Components and Drug Product Containers and Closures

    Section 5 – Operating a QC Laboratory

    • Subpart I:  Laboratory Controls
    • Sample Management and Workflow
    • Subpart J: Records and Reports
    • Good Documentation Practices/Data Integrity

    Section 6 – Quality Functions

    • Change Control
    • Tech Transfer
    • Corrective and Preventive Actions (CAPA)

    Audits – Validation – Improvement


    Section 7 – Effective Investigations

    • When Things Go Wrong
    • Handling OOS investigations
    • Subpart F: Production and Process Controls
    • Effective Investigations

    Section 8 – Stability

    • Studies to support registration and commercial
    • Accelerated and stress studies
    • Establish an expiration dating for finished products

    Section 9 – Inspections

    • Planning, techniques, reporting and follow-up actions
    • Self-Inspection and Self-Auditing 
    • Auditing external QC labs 
    • Quality Management Systems

    Section 10 – Qualification and Validation

    • Analytical method validation
    • Compendial testing and verification
    • Equipment Qualification and Maintenance  Requirements
    • System Suitability Testing: an essential component of lab compliance

    Section 11 – Computer System Qualification

    • 21 CFR Part 11 and the QC lab
    • Part 11: eSignature and eRecords

    Section 12 – FDA 483 & Warning Letters & Consent Decree

    • Examples of Observation of non-compliances – FDA 483
    • Warning letters and current hot topics in lab compliance
    • Question and Answer Period, Course wrap-up and conclusions
    • What are your top lab compliance challenges, issues, and problems?
  • Testimonials

    "The Director provided a large number of real-life examples that related to the course.  Also, she dove deeper in parts of the courses that we needed more information on.  The course was very interactive and the real-life examples given were very helpful.  I requested additional info on OOS and proper retesting plan. Director covered it thoroughly on the last day which was very helpful. Great instructor!"

    Nastassja O., Director, Lab Operations, Charles River Laboratories


    "I liked the instructor’s approach and the smaller class setting. There was A LOT of material to learn.  I enjoyed her anecdotes and experiences. She did a great job on certain slides really engaging us and VERY clearly explaining/ensuring we understood important bits."

    Melissa W., Preconstruction Manager, Turner Construction


    "I enjoyed the small class size and the great interaction with the instructor, as well as the correlation of information with real life experiences"

    Becky W., QA Manager, Avero Diagnostics


    "Lots of great info, my brain feels full! Also great accommodations. Numerous real life examples."

    Jacquie W., QA Specialist, Novavax


    "Good overview and the instructor was full of good experiences."

    Rachel A., Manager Quality Control, Biomerieux


    "Dynamic presentation style kept my interest. Practical examples were really useful in making course material relevant. Length of course was good; not too long and not too condensed. Course material was well developed and nicely presented for attendees."

    Diana B., QC Chemistry Manager, Allergan


    "The instructor was extremely energetic and maintained focus of the entire group at all times. Never once did I look at my watch to see how much longer we had to go. He was extremely well versed in all areas and offered appropriate examples to drive home all key concepts."

    Lauren B., Project Manager, Chiron


    "The course was very informative and lots of useful information was presented. The instructor handled a number of difficult questions and I learned a great deal from others in the course."

    John M., Quality Manager, Berlex


    "The material and speaker was great. I liked the examples that he used to convey the material. I appreciated allowing as many students' questions as he did. The recommendation given to read the secondary materials; such as website literature, court cases, and guidance documentation was very helpful. I would look for more classes to take from this course director and company again."

    Kristi C., Lab Technician

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.

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