GMP Training for the QC Laboratory

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

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?

"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