Applying the GMPs Training Course


The highly interactive classroom course uses extensive exercises to provide an intense examination and interpretation of the cGMP regulations with special emphasis on applying the "right dose" of GMP to various situations to assure that methods, facilities, and controls are used for the manufacture processing, packing, or holding of drug products to meet requirements for safety, identity, strength, quality, and purity. The regulation will be divided into six elements: materials, buildings, equipment, records, procedures, and people. Participants will focus on compliance strategies for interpreting the controls needed to continuously operate in a state-of-control, validation, cleaning, and training interpretations will be discussed throughout. Specific case studies will be evaluated by the participants while the concept of regulatory inspections is covered along with an examination of the USFDA's quality system inspection techniques and the European inspection practices. Special emphasis will be placed on both cGMP compliance cGMP performance issues. Note: We recommend attendees have a least two years of experience with the cGMPs to attend this course.

Course Modules

  • Quality Systems Management 
  • Organization and Personnel Equipment 
  • Control of Materials 
  • Production Controls 
  • Packaging and Labeling 
  • Laboratory Controls 
  • Documentation 
  • Compliance Program Guidance

Take Back to Your Job

  • Discuss specific strategies for interpreting the Title 21 CFR, Parts 210/211,  and the European references for GMP regulation
  • Apply and discuss regulatory systems such as the quality system management, building and equipment requirements, personnel, material control, production controls, packaging and labeling systems, laboratory controls and good documentation practices
  • Examine and discuss GMP concepts beyond basic elements
  • Learn what Quality Systems Management is and how it effects your interpretation of the current regulations
  • Learn to properly discuss key GMP elements and learn the current interpretation and best practices based on the latest interpretation of regulations (understand the usual, customary practice)
  • Develop a specific GMP compliance plan and strategy for complying with the regulation
  • Define the concept of "usual and customary practice" and how it applies to regulatory inspections

Attendance Recommended For

Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

Personnel who need an in-depth understanding of the European and US regulations

Service organizations, suppliers, and vendors who serve pharmaceutical industry clients

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Process/Product development Community of Practice (COP).

Daily Schedule and Pricing

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information