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cGMP, GLP, GCP training

Learning Objectives

Learning Objectives
  • All participants will gain a fundamental knowledge of the basis of cGMP, GLP & GCP 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 , GLP & GCP 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.
  • Course Description Good Manufacturing Practice regulations (cGMPs) apply to pharmaceutical, biotech and medical device products regulated by FDA. This course explores the content and interpretation of the regulations, with emphasis on the necessary practices, procedures and documentation required to achieve full compliance. The course will utilize case studies to facilitate interpretation and application of regulations. The attendees will gain understanding of how knowledge of the regulations facilitates efficient and cost effective issue resolution.
  • The first day of the course introduces students to the Food Drug and Cosmetic Act, principles of pharmaceutical GMP regulations and navigating FDA enforcement. The second further examines application of GMP regulations in the pharmaceutical and biotech industries, medical device quality system regulations, and review of case studies for the practical application of regulations. The third day details the controls and process that enable effective quality management with emphasis on establishment of quality systems, management responsibilities, handling deviations and techniques for auditing and monitoring of processes to ensure ongoing compliance.
  • Course content:
  • Overview of GMP
  • Overview of GLP
  • Overview of GCP
  • ICH GCP Guidance's and its importance
  • ICH E3, ICH E6
  • Importance of PIC/S