This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who outsource GMP operations to Contract Manufacturing Organizations (CMOs) and Contract Analytical Laboratories.)
Virtual companies typically do not conduct “hands on” manufacturing, but do perform tasks which are governed by GMP, for example, dispositioning final product, managing the supply chain, investigating complaints, and providing training to staff in GMP compliance concepts. Such companies often struggle to decide how to structure their quality management system, which procedures they need or do not need, and how to best manage vendor relationships.
In addition, the application of GMP requirements to the manufacture of investigational products requires exercise of judgement over the life cycle from early phase (Phase 1) to peri-approval (late Phase 3). Understanding what is required by FDA and other regulatory agencies is important to assure timely approval, since GMP compliance issues can result in approval delays.
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.
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
Course Content
DAY 01 (11:00 AM - 5:00 PM EDT)Introduction and objectives
Course Provider
Mr David L Chesney,
Principal and General Manager ,
DL Chesney Consulting, LLC (Former FDA Director)David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC.
His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.
Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.
Who Should Attend
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
