2016 Webinar by Compliance4all on FDA and Regulatory Aspects
- Start Date:
- Tuesday, 6 December, 2016
- End Date:
- Tuesday, 6 December, 2016 11:00am
- Health & Nutrition
Overview: The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA.
Areas Covered in the Session:The Revised ISO 14971:2007 for DevicesICH Q9 for PharmaProduct Hazard Analysis Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis'Fault Tree AnalysisThe Team and It's Involvement - Who, When and HowProduct Risk Management File and ReportUsing the Completed Document - It's Real ValueKeeping it "In the Loop" Who Will Benefit:Senior Management, Project LeadersInternal / External Auditors and/or ConsultantsRegulatory Affairs Quality Systems Personnel / QAENew product development, Marketing and R&D Product and Process / Manufacturing Engineering StaffDocument Control Speaker Profile:John E Lincoln is a medical device and regulatory affairs consultant.
He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. Contact Detail: Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.comhttp://www.compliance4all.com/Event Link : http://www.compliance4all.com/control/w_product/~product_id=500884LIVE?channel=mailer&camp=webinar&AdGroup=meetings4docs_Dec_2016_SEOTwitter Follow us - https://twitter.com/compliance4allFacebook Like us - https://www.facebook.com/Compliance4allLinkedIn Like us - https://www.linkedin.com/company/compliance4all
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216