Post-Market Compliance — Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits
Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions.
Palo Alto, CA, USA November 14, 2017
New course materials have been added by Former FDA CDRH Recall Branch Chief Rita Hoffman to this seminar, updated content will include Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and What to expect from the changes in ORA with Inspection Structure Realignment.
Given the constant updates in the industry, seminar will have sessions on Complaint Handling and FDA Expectations, Medical Device Reporting Procedures (MDR), MDR FDA Perspective, User Error Malfunction, Preparing Standard Operation Programs, Recalls: Definitions and Legal Authority, Risk and Health Hazard Evaluation, Effective Communication with FDA, Product Enhancements, ORA Alignment and more.
Spend one and a half days in an interactive course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief with over 36 years with FDA and leading Industry Expert, who will provide the participants with tools to minimize risk of regulatory enforcement actions. This Seminar will have you stop spinning your wheels with nonessential activities, and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.
This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting.
For more information on this seminar, visit the event website here.
Thursday, November 16, 2017 (8.30 AM – 5.00 PM) and Friday, November 17, 2017 (8.30 AM – 12.00 Noon)
Thursday, February 1, 2018 (8.30 AM – 5.00 PM) and Friday, February 2, 2018 (8.30 AM – 12.00 Noon)
Thursday, May 3, 2018 (8.30 AM – 5.00 PM) and Friday, May 4, 2018 (8.30 AM – 12.00 Noon)
Location 1: Boston, MA
Location 2: Tampa, FL
Location 3: Pittsburgh, PA
Registration Cost: $1,699.00 per registration
Early bird discounts: For discounts on early registrations, please click here.
Register by phone: Please call our customer service specialists at +1-888-717-2436 or email to [email protected]
For more information on ComplianceOnline or to browse through our trainings, please visit our website.
ComplianceOnline is a leading provider of regulatory compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (http://www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions for global corporations.
For more information please contact:
A Reuben Bernard
Associate Director – ComplianceOnline
2600 E Bayshore Rd
Palo Alto CA USA 94303
Phone – +1-650-238-9656 | +1-888-717-2436
Fax – 650-963-2556
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