Course Information
Course Title: How to Manage a CGMP Compliant Laboratory
Categories: 1 - Management/Professional Development
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
Instructor(s): David Bliesner Course Number: 99
Course Date: 03/10/2012 - Saturday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $455 ($655 after 2/13/12) Textbook Fee:

Course Description
Very few people, including the best laboratory managers, have a true appreciation for the complexity of running an analytical laboratory in a regulated environment. To make things worse, each laboratory has its own unique set of challenges and operates differently. Therefore, whether the lab is run well or poorly comes down to the individual skills of the laboratory managers or supervisors. These facts obviously do not bid will for the long term compliant operation of the laboratory. Although standard operating procedures (SOPs) are required by the Current Good Manufacturing Practice Regulations (CGMPs) in most circumstance there is no “operations manual” for the laboratory: that is a coherent set of “how to” instructions which tie all documented and undocumented procedures together. Therefore, many of the daily, weekly, monthly, quarterly and yearly tasks reside in “someone's head”. In this course you will learn how to construct an operations manual for your laboratory through instructor-guided small group brainstorming and open forum discussions and knowledge sharing. This manual will allow you to withstand the rigors of an inspection by a regulatory agency and make your life easier by helping you to better organize and execute your work functions.

Target Audience
New laboratory managers and supervisors. More senior managers and supervisors looking to be come more compliant and efficient.

Course Outline
i. Overview of Quality Control Laboratory Operations in a CGMP Environment
ii. How to Create Your Operations Manual: Instructor-Guided Small Group Brainstorming and Open Forum Discussions
  a.Laboratory Managerial and Administrative Systems 
 b.Laboratory Documentation Practices and Standard Operating  Procedures 
  c.Laboratory Equipment Qualification and Calibration    
  d.Laboratory Facilities 
  e.Methods Validation and Technology Transfer  
  f.Laboratory Computer Systems 
  g.Laboratory Investigations  
  h.General Laboratory Compliance Practices 
iii. Additional Questions and Answers
iv. Selected References

Course Instructor's Biography
Dr. David M. Bliesner, Ph.D. is President of Delphi Analytical Services, Inc. (Delphi). Delphi provides CGMP products and services to the Pharmaceutical, Contract Analytical Laboratory, and Allied Industries. Dr. Bliesner has a doctorate in Analytical Chemistry from the University of Vermont, and an MBA from the School of Hard Knocks. He possesses a unique combination of science and business skills and experience. These skills and experiences range from analytical R&D in the pharmaceutical industry to business plan preparation and market analysis in the chromatography supplies and contract analytical and instrument services businesses. Dr. Bliesner’s expertise includes quality assurance auditing of GMP laboratories, developing and implementing corrective action plans for analytical laboratories, high performance liquid chromatography, experimental protocol design and project management, and designing, building, staffing, and qualifying cGMP/GLP laboratories. Over the last several years he has been part of the “Expert Consultant” contingent for companies currently operating under consent decree with the FDA where he has helped establish CMGP Laboratory Audit Systems. Dr. Bliesner is also author of “Establishing a CGMP Laboratory Audit System: A Practical Guide” and “Validating Chromatographic Methods: A Practical Guide” John Wiley & Sons, Inc. publishers.