ComplianceOnline

NOTE: This course focuses primarily on Pharmaceutical and Biologic GMP Inspections, though much of the information is also applicable to Medical Device Inspections and Good Clinical Practice (GCP) Inspections.

The various health regulatory authorities (FDA, EMA, TGA, etc.) all carry out their surveillance and enforcement activities via inspections, which may be pre-announced or unannounced in some cases. Companies must carefully prepare for these inspections, and manage them well when regulatory authorities are on site. As health authorities, the agencies have important work to do and certain rights of access to areas and records, but the company also has rights. To understand the system and prepare and manage inspections effectively requires knowledge.

Though different in some respects, the FDA, EMA and TGA have been working together for the past few years to better understand each other's methodologies for inspections, to learn from one another via the conduct of simultaneous inspections and to endeavor to harmonize their approach to the extent feasible.

This program will examine the methods employed by the FDA, EMA and TGA to conduct inspections; review publicly available documents from these agencies that describe their processes; and suggest best practices companies should follow when hosting inspections on their premises.

Interactive discussions of case studies will be interspersed at various points during both days to illustrate the concepts discussed.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completing this course participants should:

  • Understand the legal basis for FDA, EMA and TGA inspections
  • Understand the reasons why inspections are conducted, and the objectives
  • Appreciate the distinction between a general GMP inspection and a pre-approval inspection
  • Know where to find key references that describe each agency’s inspection activities
  • Know industry best practices for hosting inspections
  • Know how best to answer various types of questions posed by inspectors
  • Know how to compose good post-inspection correspondence to explain planned response to inspection observations, and to dispute any areas where the company disagrees with the observation
  • Recognize potential problems and pitfalls and know how to avoid them

Who will Benefit:

This course is designed for pharmaceutical and biologic personnel who are charged with hosting, coordinating or otherwise supporting health regulatory authority inspections, or subject matter experts who are called upon to answer inspectors’ questions and want a more thorough understanding of the process. The following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing supervisors
  • Quality auditors
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction and listing of participants’ objectives for the course
  • Overview of health regulatory authority inspections
    • Purpose
    • Scope
    • Objectives
    • What is at stake for the company?
    • General GMP vs Pre-Approval Inspections
    • Authority of the inspecting agencies
  • Similarities and differences – FDA, EMA, TGA
  • International harmonization efforts
    • Joint FDA-EMA-TGA activities
    • Impact of the International Conference on Harmonization (ICH)
    • Role of the PIC/S organization and impact on inspection methods
    • Recent “program alignment” initiative at the FDA and its implications
  • Information sources about inspections on agency web sites: What you need and how to find it easily
    • FDA
    • EMA
    • TGA
  • Enforcement considerations
    • FDA enforcement process – domestic and ex-US
    • EMA enforcement
    • TGA
Day 02(8:30 AM - 4:30 PM)
  • Recap participants’ objectives set at start of day one; ensure they are being met
  • Logistics for managing inspections at your site
    • 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
  • Inspections at your contract organizations
    • Making sure your CMO and contract lab are “PAI ready”
    • Training employees to assure inspection readiness – pitfalls to make sure you avoid
    • Conducting mock inspections effectively
  • 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
  • Final Q&A, discussion, and conclusion
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David L Chesney

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.

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