GMP Compliance, Regulatory Affairs & Validation Consulting and Training

Course Description

Pharmaceutical quality affects every American. Consumers expect that medicines they take will meet quality standards for safety and effectiveness. Most people, however, are not aware of Current Good Manufacturing Practices (cGMP), or how the US Food and Drug Administration (FDA) assures that drug manufacturing processes meet these basic, minimum requirements. cGMP requirements are published in the Code of Federal Regulations Title 21 CFR Parts 210 and 211 cGMP in Manufacturing, Processing, Packing, or Holding of Drugs and Finished Pharmaceuticals.

cGMPs are used by pharmaceutical and biotech companies to ensure their products meet FDA requirements for identity, strength, quality, and purity. The “c” in cGMP stands for “current”; it means a company is required to use technologies and systems that are up-to-date in order to comply with the FDA regulations. Systems and equipment that may have been top-of-the-line to prevent contamination, mix-ups, and errors ten or twenty years ago may be less than adequate by today’s standards.

The cGMP requirements are flexible, in order to allow each manufacturer to decide how to best implement necessary controls. Flexibility allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.

QSG’s cGMP course covers the requirements for establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories within a pharmaceutical production environment. Participant involvement is encouraged through the use of practical exercises, quizzes, and examples from actual companies.

Who Should Attend
This course was designed for Quality Assurance Managers, Quality Control Inspectors, Production Managers, Lab Technicians, and Maintenance Managers.

Learning Objectives
Upon successful completion of this course, participants will be able to:

  • Assess the actual systems within their own workplaces as they compare to the cGMP regulations
  • Provide direction for others in meeting the cGMP regulations
  • Understand the documentation and records needed to comply with cGMP regulations

Course Outline

  • What is cGMP?
  • Quality Unit Responsibility and Authority
  • Personnel Training and Responsibilities
  • Annual Product Reviews/Internal Audits/CAPA
  • Complaint Handling
  • Change Control
  • Recalls/Returns/Salvages
  • Stability Testing
  • Validation
  • Traceability
  • Facility and Equipment
  • Material System and Supplier Qualification
  • Production System
  • Packaging and Labeling System
  • Laboratory System
  • 21 CFR Part 11 Compliance

Course Format
8 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization

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