Managing GMP Compliance and Phase Appropriate GMP Considerations (com) A
Event Information
About this Event
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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 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.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
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
AGENDA
DAY 01(8:30 AM - 4:30 PM)
08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
Introduction and objectives
Virtual Company Challenges
Importance of quality management to business success
GMP defined and the Legal basis of GMP
Meaning of the term “Manufacturing”
CMO Role
Role of the contracting company
Specific GMP requirements that apply to virtual companies
Structuring a Quality Management System in a Virtual Company Setting
Structuring the organization and the Quality Unit
Structuring a document control hierarchy
Determining what procedures to have in place
Development of Quality Standards
Supply Chain Quality Management
Legal basis for this requirement of GMP
Vendor selection considerations
Quality Agreements
Vendor auditing system (frequency, depth, obstacles to overcome)
FDA Inspections of Virtual Companies
Authority and scope of access
Reasons for FDA inspections of virtual companies
Special considerations for Prre-Approval (NDA/BLA) inspections
Logistic considerations for managing FDA presence on site
Answering interview questions
Regulatory correspondence: Responding to FDA-483s, other post inspection correspondence
DAY 02(9:00 AM - 4:00 PM)
09.00 AM: Session Start
Phase Appropriate GMP Compliance
Legal basis
Applicability to placebos
FDA vs. EMA inspection considerations
FDA Guideline for Phase 1 GMP Compliance
FDA Guideline for Phase 2 and 3 GMP Compliance (legacy 1992 guideline no longer applicable to Phase 1)
EU Annex 13 – Investigational Medicinal Products
Importance of Data Integrity
GMP data versus “application data” and importance to PAI/PLI Success
Practical application of GMP principles to investigational drug manufacturing
Facility considerations – size, scale
Equipment qualification
Process and analytical method validation issues
Scale-up issues
Sterility and environmental control
Stability issues
Procedures – level of detail
Master and batch production and control records
Change control – at what point does this apply?
Deviation investigation
Batch disposition and role of the Quality Unit at the CMO vs the Virtual Company
Final discussion, Q&A
SPEAKER
David L Chesney
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.
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NO REFUNDS ALLOWED ON REGISTRATIONS
Service fees included in this listing.
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