Compliance Trainings, 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
2015-03-10
Description : This webinar is intended to help you adequately develop an internal audit program of a firm's quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820. 21 CFR 820.22 states "Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system." This webinar will provide great opportunities to help you adequately establish your internal quality audit program with increased awareness and familiarity by employing risk- and process-based approaches pursuant to both ISO 13485 and 21 CFR 820.22. At the end of the webinar, you will become familiar with the regulatory requirements for establishing an adequate internal audit program while bringing great benefits and added values to your firm's quality management system and contributing to saving an enormous amount of resources. This webinar is a must to attend to ensure the adequacy of your internal audit program in conformity with the requirements set out in the ISO 13485 and 21 CFR 820.22. Areas Covered in the Session : Statutes and Regulations Definitions Comparative Overview of both ISO 13485 and 21 CFR Part 820 Auditing Strategy Audit Objectives Audit Planning, Frequency, Duration and Logistics How to Audit Quality Management Systems Various Audit Approaches Quality Systems and Subsystems in ISO 13485 Quality Systems and Subsystems under 21 CFR Part 820 FDA and ISO 13485 Good Practices: Speaker’s Suggestions and Recommendations Conclusion Who Will Benefit: Quality Professionals Compliance Staff and Officers Regulatory Affairs Research & Development Chief Executive Officers Vice Presidents Attorneys Clinical Affairs Consultants Contractors/Subcontractors Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820 Price tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 For more information and enquiries contact us at Compliance Trainings 5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com Like Us On Facebook: https://www.facebook.com/events/580355818766626/?source=1&sid_create=1108234639
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