Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies (Irvine, CA, United States – March 26-27, 2020) – | Financial Buzz

Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies (Irvine, CA, United States – March 26-27, 2020) –

The “Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies” conference has been added to’s offering.

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 judgment over the life cycle from the early phase (Phase 1) to peri-approval (late Phase 3). Understanding what is required by the 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 the FDA for the 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

Seminar Fee Includes:

  • Lunch
  • AM-PM Tea/Coffee
  • Seminar Material
  • USB with seminar presentation
  • Hard copy of the presentation
  • Attendance Certificate
  • $100 Gift Cert for the next seminar


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 Pre-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


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.

For more information about this conference visit

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