cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

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COURSE DETAILS

Course Description

This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future.

Topics included are:

  • Impact of facility and equipment design on GMP compliance
  • Risk management approach to compliance
  • Vendors
  • Commissioning, Qualification and Validation – Which one to use
  • Problem resolution
  • Part 11 in production and the laboratory

A comparison between 21 CFR 210/211, 600, and 810 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current "hot" topics and examples of recent warning letters will also be discussed and evaluated.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend

This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment (from beginner to advanced professionals) and those whose roles and responsibilities require they understand and apply cGMP quality principles to their job.

The course helps the cGMP beginner by presenting important concepts in a logical and natural sequence so they can begin to understand the concepts and begin applying them. The course also helps the both the "cGMP Intermediate" and the "cGMP Professional" by providing valuable insights that will assist them in quality decision-making, as well as, demonstrating ways to make their present systems more effective.

Those seeking to better understand and implement FDA and ICH guidance publications (e.g., "The Quality Systems Approach to Pharmaceutical cGMP Regulations", Q9), will benefit from this course as it provides practical ways to achieve the quality state in this shifting paradigm. Attendees working with combination products, biological, or APIs will also gain insight on how to better structure the quality system in order to more effectively manage compliance for multiple products.

Learning Objectives

This course is designed for personnel with all levels of cGMP experience, and will provide all participants with additional knowledge to further their careers. Upon completion of this course, attendees will:

  • Be able to understand and apply GMP concepts to decision making in a managerial role
  • For the beginner, the course provides guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities
  • For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, and enhance their continuous improvement programs
  • Understand facility and equipment design implications on the final product
  • Know and understand the difference between commissioning, qualification and validation and how they are applied
  • Understand and begin implementation of FDA guidance documents such as "The Quality Systems Approach To Pharmaceutical cGMP Regulations", and other important FDA and ICH guidelines
  • Become knowledgeable in the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
  • Understand the similarities and differences between the FDA's GMP for Active Pharmaceutical Ingredients (Q7A), Drug Products (Finished Pharmaceuticals - Part 210/211), Biological (Part 600-680) and Medical Devices (Part 810)
  • Know the current compliance "hot spots" that FDA and international authorities look for when inspecting for cGMP compliance
  • Know how to better locate regulatory information and to interpret, assess, and make decisions concerning GMP issues

Past Participants' Comments

"The training you gave was extremely valuable. Being new in QA and new to the regulations, you gave me resources to find answers to the questions I had.  Based on suggestions and clarifications you provided, we have been slowly implementing new programs, that seem to mesh better with the CFRs than what we had before. It is very exciting being involved the productive changes in the way my company runs.  Thank you for giving me resources and answering my questions." Patrick B., Quality Assurance Associate, Tedor Pharma

"Small class size helped to make sure individual questions and concerns were addressed.  I thought the pace was good - covered a lot of material." Valerie J., QA Pharm Bio, W.L. Gore

"Strong instructor, very knowledgeable on the subject matter.  Concise and comprehensive." Nnodum I., President, Nnodum Pharmaceuticals

"I thought the course material was well suited for an introduction to cGMP principles. It discussed many basic parts of the process needed to run a cGMP facility in an easy to understand manner. The instructor provided many insights into the industry and demonstrated a thorough understanding of the subject matter."
Jennifer D., Process Development Scientist I, Morphotek
"Very good course! The instructor had good knowledge of both the clinical and regulatory aspects of the subject matter. I would definitely recommend this course to others." Kim Z., Sr. Engineer, Johnson & Johnson
"The course was very informative. The materials/topics such as validation & facilities are not usually covered in a class like this." Rose S., Senior QA Manager, Elan
"The course director was very knowledgeable in GMP and other areas of Quality Assurance. Relating GMPs to everyday manufacturing helped to put the GMPs into perspective. The atmosphere was very relaxing, and I felt very comfortable asking questions. I would definitely recommend this course to others." Kristen R., Plant Quality Engineer, Amway
"I found the class to be tremendously educational and the teacher highly qualified." Ronit A., DRT Labs

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