CGMPs In-Depth Analysis for Pharmaceutical Life Cycle Management

Who Should Attend
This practical course is intended for professionals in the pharmaceutical, biotechnology, dietary supplements, cosmetic and related industries, including:

  • Supervisory and training staff
  • Management level staff – all departments
  • Investigation Writers and reviewers
  • Validation staff
  • Internal auditors (site and corporate)

It is most beneficial to manufacturing personnel involved in:
  • Manufacturing operations including packaging and the
    laboratory
  • Writing validation documents (including Master Plans)
    Higher level technical and managerial personnel will find the
    course a worthwhile overview of the basics based on new
    FDA guidance effective 2011.

Description
This course will provide an orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical product. The course will cover techniques and practices to ensure compliance with these regulations including manufacturing, packaging, holding, distribution and the laboratory. It will provide a practical application of the cGMP on the operating level. Actual experiences and case studies will be included. Ample time will be given to the specific problems of participants. This course will prepare first-line supervisors and will provide an update to managerial level staff to successfully discharge their responsibility for implementing a firm’s QMS.