Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs) and Contract Laboratories, however, remain responsible for the quality and compliance status of the products they send to the clinic or to the marketplace.
In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.
You will also learn best practices for managing a regulatory inspection, with emphasis on FDA, EMA and Health Canada, but applicable to most other major agencies as well.
Learning Objectives:
Participants in this seminar will:
- Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations
- Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories
- Learn the elements to include in a quality agreement (also known as a technical agreement)
- Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource
- Understand your obligations under the law for products you release to the clinic or the marketplace
- Appreciate the importance of maintaining data integrity
- Learn how to effectively manage a health regulatory inspection:
- Inspection logistics
- Responding effectively to document requests and questions from inspectors
- Managing the inspection exit discussion
- How to write an effective response to inspection observations
- How to find applicable inspection references and procedures of the FDA, EMA and Health Canada
Who will Benefit:
This course is designed for those charged with managing Quality Assurance and Regulatory Affairs for companies in the development or commercial phase of growth who either release investigational drugs to clinical trial sites or send commercial products to the market, but rely to a great extent on the use of Contract Manufacturers and/or Contract Laboratories. The following personnel will benefit from the course:
- Senior quality managers in manufacturing QA/GMP or clinical quality areas
- Quality professionals
- Regulatory professionals
- Clinical Operations
- Compliance professionals
- Quality auditors – GMP and GCP
- Document control specialists
- 8:30 AM Welcome and Introduction
- Introductions and participant expectations for the program
- Virtual company business model and compliance challenges
- Virtual company organizational structure and responsibility for QA/GXP
- Introduction to FDA law, regulation and “GXP” Concepts
- Laws
- Regulations
- Guidelines
- Fundamentals of Good Manufacturing Practice
- What is GMP?
- Purpose of GMP
- Basis in law: US, Europe, Canada
- Elements that apply to all virtual companies
- Elements that depend on how operations are conducted: How to tell what applies to your company
- Fundamentals of Good Clinical Practice
- What is GCP?
- FDA Regulations vs ICH Guideline E6 – US vs other venues
- Key sponsor responsibilities
- Key trial site (clinical investigator) responsibilities
- Data Integrity: What it is and why it is important to GMP
- Pharmacovigilance – pre and post market – FDA and EMA differences
- Building a GXP Quality Management System
- Policies, procedures, documentation management
- Metrics and management review considerations
- Selection, qualification and monitoring of contractors
- Initial due diligence – public information sources to gage compliance
- Qualification of vendors
- Quality agreements – determining and documenting responsibilities for GMP
- Vendor audit program
- GCP implications
- Day One Q&A and recap of progress meeting stated course expectations
- 16:00 End of Day 1
- 8:30 AM Recap Day 1 then Day 2 Content
- Phase appropriate GMP considerations – investigational drugs vs commercial
- Regulatory Inspections
- Purpose of an inspection
- Reasons for inspections
- Inspections at virtual company headquarters locations – purpose and scope
- Inspections at CMOs and Contract Labs
- GMP inspections versus Preapproval inspections – FDA
- Logistics for managing inspections at your location
- Information sources about inspections on agency web sites: What you need and how to find it easily
- Preparation for inspections
- Overall process – ready room support
- Receiving and hosting the inspectors
- Providing documents
- Answering questions
- Interpersonal dos and don’ts for interacting with inspectors
- Managing the exit discussion at the conclusion of the inspection
- Post-inspection communications with the inspecting agency
- How to write an effective response
- Common mistakes to avoid
- Following up to ensure the response is satisfactory
- When to request a meeting, and if granted, how best to handle it
- Inspections at your contract organizations
- Making sure your CMO/CDMO, CRO and contract labs are “PAI ready”
- Training employees to assure inspection readiness
- Conducting mock inspections effectively
- Enforcement considerations
- FDA enforcement process – domestic and ex-US
- FDA and other agency web site resources – what, where, how to use
- Final Q&A, discussion, and conclusion
- 16:00 End of Training Course
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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