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

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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