Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
Details
In this two half-day workshop conference you will learn how GMP applies directly to virtual company operations, how to best structure a quality management system in a virtual company, and a method to decide which procedures are necessary at what points
in time. You will also learn best practices for quality agreements and vendor management. In addition, you will learn the current guidance from FDA for application of GMP to the manufacture of Phase 1, 2 and 3 clinical trial materials. Though FDA requirements
are the primary emphasis, some discussion of EMA (European) requirements and other venues will also be included.
Outline
Learning Objectives:
Upon completing this course participants should:
- Understand the fundamentals of GMP for the United States
- Understand how to determine what GMP-governed operations you are performing internally versus what you are outsourcing
- Understand a method to structure your quality management system and decide which procedures you need now versus which ones can wait
- Understand best practices for vendor management
- Learn how to apply GMP concepts to Phase 1, 2 and 3 investigational drugs
- Learn the differences between an FDA GMP inspection, a Pre-Approval Inspection and a Pre-License Inspection and where to obtain guidance for each
- Understand basic principles of FDA inspection authority, what to expect if FDA inspects your virtual firm, and how to manage the presence of FDA personnel on site
Who will Benefit:
This course is designed for persons responsible for GMP compliance management following a virtual model, both pre- and post-market. Though designed with small company needs in mind, the principles are also useful to those in larger companies who manage CMOs, particularly those manufacturing investigational drug API and finished products:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Quality engineers
- Quality auditors
Speaker/s
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He has 47 years experience, evenly divided between the FDA and the private sector, including over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.
Mr. Chesney has an MS degree in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of the Parenteral Drug Association, where he serves on the faculty of the PDA Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.
Special Offer
For Registration - http://www.complianceonline.com/fda-gmp-expectations-phase-i-first-in-man-clinical-trials-iso-9001-2015-qms-cmc-seminar-training-80366SEM-prdsm?channel=speedycourse
Note: Use coupon code NB5SQH8N and get 10% off on registration.
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
