Compliance Trainings, Online
2016-06-06
Description : The United States Food and Drug Administration (FDA) FDA has been utilizing information based on inspections conducted by third parties and other regulators in different circumstances pursuant to MDUFMA 2002. Beginning in January, 2014, the FDA has been participating in a pilot program entitled “Medical Device Single Audit Program (MDSAP)” with other international partners. The MDSAP is intended to allow MDSAP recognized organizations to conduct a single audit of a medical device firm that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program. For global medical device firms to be ready for auditing for quality management systems in accordance with the ISO 13485, it is imperative that firms become familiar with the recent changes made to the ISO 13485. This webinar is intended to help you get familiar with the changes in the recent 2016 March version of ISO 13485 including differences with ISO 13485:2003. This webinar will help you better understand, increase your awareness and familiarity with the recent ISO 13485:2016. This webinar will provide great opportunities to develop your insight on what is best for your business under limited resources and circumstances when considering implementing ISO 13485:2016 for regulatory and certification purposes. Areas Covered in the Session : Applicable Laws Regulations FDA Guidance Major Misconception Definitions ISO 13485 (March, 2016 version) Differences between ISO 13485:2003 and ISO 13485:2016 Common Non-conformances During Regulatory Audits Global Aspects of ISO 13485 Quality Management System (QMS) ISO 13485:2016 Transition for Regulatory and Certification Speaker’s PASS-IT Recommendations: Best Practices Who Will Benefit: CEOs VPs Compliance Officers Attorneys Regulatory Affairs Clinical Affairs Quality Assurance Research & Development Consultants Contractors/Subcontractors Anyone Interested in the ISO 13485:2016
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