ComplianceOnline

Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules

Instructor: David Dills
Product ID: 700744

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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Read Frequently Asked Questions

Why inspections are conducted and by what statutory authority?

Description

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.

This session provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, etc. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.

Areas Covered in the seminar:

  • Why inspections are conducted and by what statutory authority?
  • The emphasis on systems-based inspections…and the IOM and other crucial FDA reference documents.
  • What is subject to FDA purview and what's off-limits?
  • Understand and apply the do's and don'ts and comprehend that preparation is the key to success.
  • What are the prohibited "Acts" and the enforcement categories that you need to deal with.
  • What you need to know and do to prepare for, during and even after the inspection…and why your inspection response team is key?
  • The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel.
  • How to respond to findings and facilitating the documentation and remediation process…and reaching final closure?

Who will benefit:
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The employees who will benefit include:

  • All levels of Management for all departments
  • QA/QC/Compliance/Regulatory Affairs
  • Information Technology/Marketing & Sales
  • Engineering/Technical Services/Validation
  • Consultants
  • Operations and Manufacturing

Instructor Profile:
David R. Dills, is Senior Consultant with PAREXEL Consulting .Prior to joining the consultancy Mr. Dills has provided independent consulting on technical and regulatory compliance to pharmaceutical, Class I, II, and III, medical device, and biotechnology companies with an emphasis on establishing sustainable compliance and validation environments. Mr. Dills also served as Director of Publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. Dills has been affiliated within the FDA-regulated industry for more than nineteen years in the areas of Quality Assurance, Quality Engineering, Validation, Regulatory Affairs/Compliance, and Corporate/Operations Management and employed on behalf of well-known, globally recognized manufacturers and service providers.

Mr. Dills areas of expertise include, but not limited to, deploying and implementing validation programs, supplier/vendor qualification, Quality Systems, Validation and other customized training, auditing, QMS policy and procedure development/implementation from cradle to grave, project management, risk management/assessment/risk-based tools and techniques, ISO 9001/13485/14971, MDD 93/42/EEC, conducting Gap Assessments and defining Remediation/CAP activities, Computer and Software Validation/IT Network, Part 11, change control, use of quality and statistical tools and techniques, design controls, CAPA, all aspects of regulatory submissions for Agency approval from authoring to review, and working with international groups/regulations, FDA Mock and PAI Inspections, PDMA/sample accountability, and other related functions and tasks.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published numerous validation and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

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