How to Manage a Medical Device Recall Efficiently and Effectively by compliance2go


									 Live Webinar on: How to Manage a Medical Device Recall Efficiently and
 Monday, June 20, 2012 duration : 01:00 to 02:00 PM EDT


                                         Recall means the correction or removal of a device
                                         for human use where FDA finds that there is a
                                         reasonable probability that the device would cause
Get 15 % Discount as a early bird        serious, adverse health consequences or death. It
registrations. Use Promo Key :           is an action taken to address a problem with a
 CGO15                                   medical device that violates FDA law. Recalls
                                         occur when a medical device is defective, when it
                                         could be a risk to health, or when it is both
                                         defective and a risk to health. A medical device
                                         recall does not always mean that you must stop
                                         using the product or return it to the company. A
                                         recall sometimes means that the medical device
                                         needs to be checked, adjusted, or fixed. If an
                                         implanted device (for example, a pacemaker or an
                                         artificial hip) is recalled, it does not always have
                                         to be removed. When an implanted device has the
                                         potential to fail unexpectedly, companies often tell
                                         doctors to contact their patients to discuss the risk
                                         of removing the device compared to the risk of
                                         leaving it in place. FDA classifies medical device
                                         recalls into three categories, representing the
Pricing                                  potential risk to public health: Class I, II, and III.

Live ( Single registration ) : $189.00   Why Should You Attend
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289     • Create and use a recall operational procedure
Get Training CD : $329                   and what should it contain

                                         • Understand what effectiveness checks are

                                         • What happens in a medical device recall?
Who will benefit                    • Learn why a recall is either a correction or a
                                    removal depending on where the action takes
Manager, Regulatory
                                    • Understand what is required for the recall
Director, Regulatory                strategy as expected by FDA

Legal Counsel                       • Source of recall authority and guidance

                                    • Depth of recall and using a viable, sustainable
Regulatory Affairs Specialist
                                    and effective strategy
Marketing        and        Sales
                                    • Understand why the documentation and paper
                                    trail are so critical and termination of a recall
Regulatory Consultants              • Snapshot of most recent recalls and why the
                                    numbers are alarming

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                                    About Speaker

                                    David R. Dills, Principal Consultant, PES-RAQA,
                                    Medical Device Practice, Wipro Technologies,
                                    currently provides regulatory and compliance
                                    consultative services to global medical device and
                                    pharmaceutical manufacturers, and also has an
                                    accomplished record with more than 23 years of
                                    experience with Class I/II/III medical devices, In
                                    Vitro diagnostics, and pharmaceuticals in the
                                    areas of QA, Regulatory Affairs and
                                    Compliance.Since 2000, has provided consultative
                                    services on behalf of global manufacturers and
                                    subcontracted by third-party consultancies and
                                    provides services involving all phases of the
                                    product development, submission, and
                                    commercialization process, inspection readiness
                                    preparation, GxP/strategy/risk management,
                                    audits and regulatory assessments, remediation
                                    and regulatory strategies, postmarketing
                                    surveillance/vigilance reporting, clinical affairs,
                                    deploy and remediate Quality Management and
                                    documentation systems, preparation for ISO
                                    13485 registration and CE Mark, and multi-
                                    country product registrations and licensing. He
                                    has been previously employed, with increasing
                                    responsibilities by medical device manufacturers
                                    and consultancies, including a globally recognized

                      Compliance2go |
                      Phone : 877.782.4696 | Fax : 281-971-0286
                        Email :

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