Are you prepared for a regulatory audit from FDA or any other regulatory body?


Instructor: Philip Russ
Product ID: 703355
Training Level: Intermediate to Advanced

  • Duration: 90 Min
This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
Last Recorded Date: Apr-2014


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
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Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
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Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

Pharmaceutical, Medical Device and Biologics industries are subject to oversite inspections by FDA and other regulatory bodies from the geographies where products are marketed. A firm’s successful completion of a regulatory audit is critical to its continued operation and financial viability. Failure can mean delays in product approvals, time consuming and costly remediation efforts and damage to the firm’s reputation for high quality products.

This webinar will provide essential information and a strategy for being in a permanent state of readiness for a regulatory audit. You and every member of your team can benefit by becoming acquainted with the overall audit readiness process and preparing them for the potential of being interviewed by an auditor.

Areas Covered in the Webinar:

  • The regulatory audit process
  • Roles and responsibilities of audit participants
  • Preparing to provide expert testimony on your quality system
  • Preparing subject matter experts
  • Types of audit questions and appropriate answers
  • Guising auditors to your quality system’s strengths instead of weaknesses

Learning Objectives:

  • Understand the tools needed to accomplish tasks related to regulatory audit readiness
  • Understand regulatory authorities’ audit processes
  • Understand your role and responsibility during an audit
  • Use techniques to establish yourself as an expert in your functional area
  • Use techniques to formulate responses to various types of questioning used by FDA and other regulators
  • Use strategies for guiding auditors to your quality system’s strengths instead of weaknesses

Who Will Benefit:

  • Regulatory Compliance Associates and Managers
  • Manufacturing operations managers and associates
  • Technical service managers and associates
  • R&D managers and associates
  • Product mangers
  • Project managers
  • QA/ QC managers
  • Documentation

Instructor Profile:

Philip Russ, is an experienced quality/compliance professional with 20 years experience in the pharmaceutical, medical device and biologics industry. He has a record of success developing and managing quality systems to support these businesses.

He has a breadth of experience performing/coordinating compliance audits involving CFR210/211, CFR820, ISO13485, QSR/PAL and CMDCAS regulations.

Mr. Russ has provided expert counsel in quality systems for early development projects; pioneering drug/medical device/drug combo quality systems and compliance initiatives; designing statistical and attribute analysis programs for manufacturing processes; continuous improvement, auditing, supplier quality management, technology transfer and validation support; statistical process controls; QA expertise for development activities, design controls and GCP for both medical device and drug products.

Mr. Russ is the owner and principal consultant of ICGXP. ICGXP offers a range of regulatory compliance and quality assurance services. Inspection readiness is an expertise that Mr. Russ and his team of associates provide clients to benefit their compliance profile and foster success in the market place.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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