Good Manufacturing Practices (cGMP) Training

All participants will gain a fundamental knowledge of the basis of CGMP regulations, and the necessity of implementing them in daily operations. Additionally, this course is intended to give participants an introduction to the CGMP regulations and their application to laboratory activities, manufacturing processes and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.

The course also provides participants with an understanding of common terminology and the role GMPs play in their day-to-day responsibilities. Focus is given to the regulatory nature of CGMP compliance, managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts. Consequences of non-compliance will be examined to underline the importance of implementing and maintaining a robust CGMP posture.

• Be able to understand and apply GMP concepts to decision making in a managerial role
• Understand facility and equipment design implications on the final product
• Know and understand the difference between commissioning, qualification and validation and how, where and why they are applied
• Become knowledgeable of the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
• Know how to better locate regulatory information and interpret, assess, and make decisions concerning GMP issues

Setting the Foundation

• Course Introduction, Expectations and Learning Objectives

• Good Manufacturing Practices

        • Definitions 

        • Importance 

• Food & Drug Administration (FDA)

        • History and Mission        

        • 21st Century Initiative

        • Food Drug and Cosmetic Act

        • 21 Code of Federal Regulations (CFR)

        • Guidance Documents

• Global Perspectives

        • International Regulatory Agencies

        • EU & ICH

• Organization and Personnel

        • Roles/Functions/Responsibilities 

        • Quality Management System 

        • Metrics

        • Signatures & E-Rec/E-Sig

        • Training & Qualification

Building a GMP Operation

• Facilities & Equipment

        • Plant & Buildings

        • Types of Facilities

        • Flows (Material, Air, Personnel) 

        • Equipment

        • Utilities

        • Functional Expectations

• Materials Control

        • Material Handling

        • Supplier Audits/Incoming Materials

        • Components/Containers/Closures

• Production & Process Control

        • Change Control

        • Master and Batch Records / Device History

        • Contract Manufacturers 

• Packaging and Labeling

        • Operations

        • Label & Labeling Control

• Validation

        • Types & Qualifications

        • Process Validation

        • Validation Master Plan

The Quality System

• Laboratory Controls

        • Infrastructure

        • Sampling/Samplings Plans

        • Analytical Methods, Validation

        • Documentation & Data

        • Equipment/Instrumentation

        • Materials and Reference Standards

        • OOS

        • Contract Laboratory 

• Product Release

        • Lot Disposition

        • Warehousing & Distribution

        • Returned Product/Recalls

• Documentation and Investigations

        • Documentation Management

        • Deviation Management System/CAPA

        • Complaints & Internal GMP Audits

• Quality Systems

        • Six-System Approach

        • Model

"The course was very intense and covered several important topics. I enjoyed learning about GMP regulations and also some historical facts of the FDA."

Ilaria C., Senior Program Manager, Icahn School of Medicine Mount Sinai Hospital

"This course gives significant in-depth knowledge, and the trainer is friendly and professional.  CfPIE courses provide all the training topics that I'm interested in."

Philip N., Manager, QA Operations, Cytokinetics

"I found the examples provided very useful and the way the instructor shared information was clear and easy to understand. The topics presented were exactly what I needed, and the instructor was engaging and very knowledgeable."

Amy M., Senior QA Specialist, Vertex Pharmaceuticals

"I enjoyed the personal experiences that the instructor shared as learning examples.  All topics were thoroughly covered."

Jaime B., QA Specialist, Waisman Biomanufacturing

"The combined knowledge and experience of the instructor was excellent."

Dominique S., Chemist, Alchemix

"Significantly better that other training providers. I enjoyed the experience and examples the instructor provided."

Lynn J., Training & Systems Senior Assoc., Insmed

"I will definitely recommend this course to my coworkers. I'm looking forward to taking other courses offered by CfPIE."

Juan O., Quality Operations Specialist, Kaiser Permanente

"Very informative course and great topics! I enjoyed the cleaning validation topics and the processes involved in a lot of different departments."

John A., Sanitation Manager, VitaQuest International

"I wanted to thank the Course Director for a great course. I’ve already started to apply and share some of the information I learned."

Stephen A., Senior Manager Cell Derivation Unit, ATCC

"The course was very relevant and useful to what I’m doing day-to-day. I very much enjoyed the topics of facility commissioning, equipment qualification and process validation."

Dennis D., Senior Director, MTA2

"I found the real-life examples and the anecdotes of the instructor's extensive industry experience very useful."

Ken O., Engineering Manager, DNA Genotek

"This course was well structured with comprehensive material and a very knowledgeable Course Director. Additionally, it was highly interactive."

Prasanna V., Process Engineer, MTA2

"This course was great! I enjoyed the numerous examples provided in class from the instructor vast experience."

Sharmila M., Process Engineer, MTA2

"This my first GMP course and it was a great learning experience! The examples the instructor used made the training fun and easy to understand."

Linda T., Project Manager, Oncolytics Biotech

"The course instructor showed lots of real-life experience that helped us understand current industry regulations and expectations."

Muthu D., QA/RA Manager, Mitra RxDx

"Well organized, thorough and very professionally delivered. Well Done!."

Jon T., Quality Director, Closure Systems International

"The Course Director had a lot of experience in a lot of different areas. I appreciated that he shared them with us. You could tell he knows what he’s talking about. The instructor’s level of experience is typical of other CfPIE courses I’ve attended."

Ashley G., Doc Cntrl/Training Spec, Wright Medical

"The course provided a thorough introduction to 21CFR and regulatory agency principles. I enjoyed the open discussion and numerous real life examples."

Aimee S., QA Specialist, Selecta Biosciences

"The course provided great examples and the Director was very engaging."

Jordan O., QA Training Specialist, Akorn

"The instructor was knowledgeable and had a good sense of humor."

Anthony R., Compliance Auditor, Clorox

"I’d rate this course as above average as the instructor was experienced, led the course at a perfect pace and was well prepared."

Betty E., Sr. Dir., FP&A, Reata Pharmaceuticals

"Very interactive, I have taken courses in the past in which I was talked to, not talked with. The instructor talked with me."

Homayoun S., Quality Assurance, Portola Pharmaceuticals

"The Course Director is very knowledgeable and very clear in his presentation. It was easy talking with him and he welcomed all questions. His vast and varied experience along with his stories and examples were very helpful."

Stephanie M. , QA Specialist, Mersana Therapeutics

"I only take courses with CfPIE as the instructors are so highly qualified."

Megha S., Document Control QA, Granules Pharmaceutical

"The Course Director's energy and knowledge is unparalleled."

Brett R., Chemist

"Great pace and sufficient detail and the instructor injected great examples to elaborate on the points discussed."

Doug T., Project Manager, OncoMed

"Excellent! This course was well structured and the presentation was effective. The instructor's style of presenting made the details easy to fully comprehend."

Pete D., Business Development Manager, Wacker Biosolutions

"Training was extet, Alchemixnsive and covered many topics within the industry. This was useful in that some parts, if not most, apply to everyone. The instructor has had many years in the industry. This was useful as it allowed him to have the knowledge to teach the class and share real-life examples that he had encountered over the years."

Nadia B., QC Coordinator, Biotest Pharmaceuticals

"Instructor was very knowledgeable and had numerous examples from the industry to share with the class."

Tyler L., Specialist I – QA, Emergent BioSolutions

"Very informative! Gave great examples from experience that put topics into perspective. The course materials provided were great! I am sure I will be using these for reference when I head back to work. I particularly like the definitions/terms and abbreviations."

Johana R., Regional Manager QA, Biotest Pharmaceutical

"Really enjoyed the three days of training, one of the best I've attended and really learned a lot that will be helpful in the next audit."

Jayne K., Research Analyst, Janssen Diagnostics

"This course presented ideas or techniques that are useful to me. The Course Director was very knowledgeable and presented his material very well. Great training"

Carlos, Mfg. Tech II, Biotest Pharmaceuticals

"Thank you for the amazing cGMP course! I didn't know what to expect going into the course but it far exceeded anything I would have imagined. It was very valuable and I learned so much from it! I hope to take another one of your courses in the future!"

Elizabeth F., Associate Scientist, Janssen Diagnostics, LLC

"Great course, well-presented, and informative."

Milissa R., QA Engineer, Biotest Pharmaceuticals

"The Course Director was a great instructor. His ability to get everyone into discussions over the topics was outstanding. I left there with many different ideas of how other companies approach the daily struggles we all face while complying with cGMP."

Susan, Director of Operations/Quality Assurance, RemedyRepack

"The Course Director was very knowledgeable on the subject of GMP. I very much appreciated his real world experiences."

Douglas S., Manager, External Manufacturing Operations, McNeil Consumer Health

"Really nice course! I learned a lot. Thank you"

Karla V., Project Manager; ABM Industries

"This course was a perfect introduction for me into the GMP regulations. I found the Course Director did a wonderful job in keeping us interested in the subject"

Mercedes S., Senior Scientist; Bluebird Bio

"The Course Director did an excellent job applying real scenarios to the GMPs. The 'warning letter' conversations were extremely informative and illustrated the importance of compliance. I also appreciated the discussions concerning master and control records and guidance around use, verification, and control. I enjoyed the discussion on the relationship between GMP, ICH and Eudralex. Of note, the Course Director did a great job engaging the class and creating a very interactive environment; the course went by very quickly."

Christopher P., Director of Manufacturing, Aastrom Biosciences

"The Course Director was so engaging in his style. And his first-hand experience and accumulated knowledge were immensely beneficial. I have never attended a GMP class that was so chock full of real experiences and examples. Also, the class size was perfect!"

Margaret C., Principal Scientist, Int'l Compliance, Mary Kay Inc.

"I found the course very informative and interesting, taught by a knowledgeable and engaging course director, explaining cGMP theory as well as appropriate examples."

Vilma C., Technologist, Pliva Croatia doo

"The course was very informative. The Course Director is extremely versed in the material presented, and he made it very easy for those in attendance to follow. I would be interested in receiving more training from this Course Director. I would recommend this class to everyone in this business."

Elder B., Mfg. Tech., Biotest Pharmaceuticals

"The Course Director's Background was very relevant and provided a very sound approach on GLPs & GMPs. I appreciated the real-life application and knowledge."

Mark W., Senior Analytical Chemist, Rockline Industrie

"This was the first time an instructor has covered all topics…BRAVO! The Course Director was excellent in communicating his ideas because of vast experience and knowledge and they had excellent presentation skills. I especially liked the case studies and interaction."

Jennifer P., Training Site Lead, MedImmune

"Even though I am in clinical, many of the GLP/GMP specifics gave me a broader picture of where areas of GXP may intertwine. It was great to see the "big picture" in the area of pharmaceutical regulations."

Kelly F., Compliance, Pfizer

"I found the course to be extremely informative and useful as I have never worked in a GMP environment until now, and therefore this course served its purpose."

Lakshmi R., Senior Research Associate/Quality Specialist, Neose Technologies

"This course is very good for individuals beginning their understanding of GMP regulations."

John S., COO, Semafore Pharmaceuticals