CGMPs 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.

Course 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.

Course Director
	Joanna Gallant; Owner & President, Joanna Gallant Training Associates, LLC

Joanna Gallant is a solutions-driven Quality and Training professional with over 20 years of technical and operational experience. She is an experienced training leader with a demonstrated ability to succeed and solve problems, and is known for designing, developing and delivering strong, interactive and effective GxP/ISO-related training. Over her career, she has provided regulatory, technical, skill, and management development training support to all Operations functions as well as IT, R&D, Customer Service and senior management. She regularly speaks at industry meetings and conferences on topics including root cause analysis, design and development of competency-based and interactive training. Ms. Gallant is fluent in a variety of global regulations and standards, including US, EU, PIC/S & WHO GMP; 21 CFR 11, 58, 600, 803, 820 & 1271; ISO 13485, and ICH Q7-10.

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