2-day In-person Seminar on Effective Complaint Handling, Medical Device Reporting and Recalls
GlobalCompliancePanel to hold two-day, in-person seminar in San Francisco, CA on the topic, "Effective Complaint Handling, Medical Device Reporting and Recalls" on April 25 and 26, 2013 (Thursday & Friday). David R. Dills, a senior Regulatory & Compliance Consultant, will be the speaker at this two-day session.
- Fresno, CA (1888PressRelease) March 26, 2013 - Venue: The venue for this seminar is the Hilton San Francisco Fisherman's Wharf.
What the seminar is about:
This seminar will familiarize participants with ways of putting an effective complaint handling system in place. A good complaint handling system is a sine qua non for any quality system. Absolutely any complaint that a manufacturer receives on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed and corrective action shall be taken.
Medical Device Reporting (MDR) is the mechanism through which the FDA receives significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. It is through this mechanism that recalls and other actions are made.
At this seminar, the speaker will enable participants to understand what actions they need to include in any system, since the FDA does not specify a standard complaint handling system. The root to understanding this is in grasping definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls. These will be imparted at the seminar.
It will help all personnel who may receive a complaint call understand the importance of getting trained in the proper routing/handling of complaints. It will address issues such as providing information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch.
It will also introduce them to the process and benefits of Voluntary Reporting and responsibilities, the latest amendments to the MDR Regulation to implement FDAMA changes, issues to consider regarding whether a Field Action is required, determine when a recall is required, and review and discuss pain points, challenges and solutions.
About the Speaker: David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.
He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.
The seminar:
The seminar will consist of the following agenda:
Day 1:
Lecture 1: Complaint Handling:
Lecture 2: Medical Device Reporting
Lecture 3: Exercise and Recap of Day 1
Quiz
Day 2:
Lecture 4: Medical Device Reporting
Lecture 5: Recalls
Lecture 6: Exercise and Recap of Day 2
Quiz
For whom:
This seminar will benefit the following:
- Regulatory Affairs Managers
- Regulatory Affairs Specialists
- Auditors
- Compliance Officers
- Compliance Specialists
- Clinical Affairs professionals
- Quality Assurance Managements
- Marketing & Sales Managers
- Distributors/Authorized Representatives
- Legal Counsel
- Engineering/Technical Services
- Operations/Manufacturing professionals
- Consultants
About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing / Clinical / Lab), EU and ISO.
Price: $1,295.00
Register now and save $200. (Early Bird)
Until March 29, Early Bird Price: $1,295.00
From March 30 to April 23, Regular Price: $1,495.00
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support ( @ ) globalcompliancepanel dot com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php
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43337 Livermore Common, Fremont CA 94539, USA
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