Good Manufacturing Practices (GMP) Training for the Quality Control (QC) Laboratory

This QC Laboratory GMP training course is intended to give participants a thorough overview and practical understanding of cGMP for laboratory compliance, including:

• General requirements for the design and construction of analytical laboratories.
• Calibration and qualification of the instrumentation and equipment.
• Documentation, records-keeping and change control.
• Management of reagents, test solutions and reference standards.
• Personnel development and training.

Learn what to expect throughout each session in this laboratory GMP course. The first half of our training covers relevant regulations, guidelines and issues within the pharmaceutical, biopharmaceutical and biologics industries. The second half covers the guidelines for necessary audits, validation and improvement processes. 

Session 1: Introduction

At the start of the program, the course director will cover the following:

• Agencies and guidance documents
• Overviews of Code of Federal Regulations (CFR) Title 21, Parts 58, 210 and 211, an abbreviation and acronym primer

Session 2: Title 21 Overview, Part 58, 210 and 211

In the second session, this course covers the FDA's involvement in the history of GMPs. 

Session 3: Phases of Drug Development

Next, attendees will review the professional designs of a QC laboratory. 

Session 4: GMP for Human and Animal Drugs

We provide a 21 CFR 211 training program, which covers the following topics:

• 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

Our training covers laboratory investigation techniques with:

• Subpart I: Laboratory controls
• Sample management and workflow
• Subpart J: Records and Reports
• Good documentation practices and data integrity

Section 6: Quality Functions

The next section covers change control and tech transfers with corrective and preventive actions (CAPA).

Section 7: Effective Investigations

We share what to do when things go wrong, including the best practices for OOS investigations. This section explains the effective investigation protocols covered in Subpart F's guidelines for production and process controls.

Section 8: Stability

This course provides a comprehensive overview of various studies, from support registration and commercial guidelines to accelerated and stress studies. We share how to establish an expiration date for finished products. 

Section 9: Inspections

Our program shares what's necessary for inspection planning, techniques, reporting and follow-up actions. The learning material covers self-inspection and self-auditing, as well as auditing external QC labs and quality management systems. 

Section 10: Qualification and Validation

Course attendees will learn the protocols of analytic testing workshops, including analytical method validation, compendial testing and verification. We cover essential components of lab compliance, from equipment qualification and maintenance requirements to system suitability testing.

Section 11: Computer System Qualification

We discuss industry-related guidelines and expectations for the following:

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

Section 12: FDA 483 and Warning Letters and Consent Decree

At the end, we share examples of observed FDA 483 non-compliances and warning letters. We encourage attendees to participate in conversations about the industry's current hot topics, and we have a question-and-answer period to wrap up the course. Attendees will hear their peers' takeaways for top lab compliance challenges and issues. 

We're committed to providing comprehensive, educational experiences that help professionals advance in their careers or renew their job requirements. See what customers say about our QC laboratory and pharmaceutical testing documentation course.

"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