Applying the GMPs (G03)

Level: Advanced - Application
Type: Classroom Training Course
ISPE CEUs: 1.3

Date Location Country Instructor(s)
This course is not currently scheduled, but may be conducted at your company. Please contact ISPE for more information.

Description

The highly interactive 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 System 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 and 211 of and the European Community and are the 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).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.