Virtual companies are defined as those who conduct no hands-on manufacturing, opting to outsource their manufacturing activities to contractors.
Virtual companies are often challenged to understand whether or not any aspects of FDA’s Good Manufacturing Practice (GMP) regulations apply to them, and if so, which ones, and whether FDA will inspect them or not.
Virtual companies also frequently fail to understand the FDA inspection process, how to prepare, what their rights are, what FDA’s rights are, and how to effectively manage the presence of FDA personnel on site.
This program addresses those needs and more.
The program includes a comprehensive review of the laws governing pharmaceutical manufacturing, the GMP regulations, and explains the responsibilities of virtual companies for GMP compliance.
The program also explains the legal basis of FDA inspections, what the FDA has the right to do during an inspection, what the law prohibits the FDA from doing, how FDA observations are communicated and how to effectively respond orally and in writing. The program also provides information about how to manage the presence of FDA personnel on site and how best to answer interview questions.
For companies who are still in investigational product stages, the program explains the requirements for the manufacture of investigational drugs (both conventional and biologic products), and how to determine what is required when guidance is lacking or unclear.
Why Should you Attend:
Attendees will learn the legal basis of GMP, the regulatory hierarchy (laws, regulations, guidance documents and the role of company procedures), and how to determine what is required for finished products, active ingredients, and investigational drug products.
The program will explain how to determine the needed elements of a quality management system, how to decide which procedures are necessary, and how to configure the system for future growth.
The program will also cover the FDA inspection process, and introduce participants to key FDA documents that explain the process in detail and facilitate effective preparation and management of FDA inspections.
Areas Covered:
- Introduction to FDA law, regulation and “GXP” Concepts
- Fundamentals of Good Manufacturing Practice
- Data Integrity: What it is and why it is important to GMP
- Building a GXP Quality Management System
- Selection, qualification and monitoring of contractors
- Phase appropriate GMP considerations – investigational drugs vs commercial
- Preparing for and Managing FDA Inspections
- Enforcement considerations
- Final Q&A
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Who will Benefit:
- Quality Assurance Professionals
- Regulatory Affairs Professionals
- Internal and vendor GMP auditors
- Executive leadership of virtual companies
- In-house legal counsel
- Others with interest in or responsibilities for the topic areas
- 9:00 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
- 15:00 End of Day 1
- 9:00 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
- 15:00 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.
