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:
Who Will Benefit:
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.
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.If you have any concern about the content of the webinar and not satisfied 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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