Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies: 2-Day In-Person Seminar by Ex-FDA Director

By: David L. Chesney, Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Location :- Irvine, CA | Thursday, March 26, 2020 | Friday, March 27, 2020

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Course Description:

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.

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

Course Outline:

Day One (8:30 AM - 4:00 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 Two (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

    Meet Your Instructor

    David L. Chesney
    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.

    Location :
    Irvine, CA (Venue to be announced shortly)
    March 26-27, 2020
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    $1,499

    Seminar One Registration

    March 26-27, 2020, Irvine, CA
    (Registrations till February 20, 2020 - $1499)
    (Registrations after February 20, 2020 - $1899)

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    Testimonials

    What past attendees say:

    I enjoyed the practical answers and lessons learned as shared by the presenter. Grateful for the sharing of presentation material (soft copy). Thanks to ComplianceOnline for timely response and communication. Variety of choices is extensive good and easy to register.
    - Manager, Process Optimization, Prolong Pharmaceuticals, LLC

    Excellent instructor and he was easy to follow and I like the thorough and thoughtful answers of my questions.
    - Senior Scientist, CCS Associates

    Instructor is very knowledgeable and good in explaining regs and guidance. Information provided along with soft copy of slide is a great idea and very helpful.
    - Sr. QA Manager, Theravance

    Overall a good general overview. The amount of interaction between the participants and presenter was good.
    - Asst. Director QA, Clinical Packaging, Abbott Labs

    GMP expectations was the most valuable topic for me. Face to face interaction and networking was good.
    - Director of Pharmacy, Pfizer New Haven Clinical Research Unit

    Speaker’s knowledge was higher than I had hoped.
    - Director, BioMed IRB

    For me the whole event was very good. I had no knowledge of the topic prior to this seminar. The presentation was excellent and the speaker was very knowledgeable and respectful.
    - Quality Assurance Specialist, Therapure Biopharma Inc.

    I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
    - Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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