Live -In-Person Seminar on “Effective Complaint Handling, Medical Device Reporting and Recalls”

Organization: GlobalCompliancePanel

Venue: Hilton San Francisco Fisherman's Wharf

Location: San Francisco, California, United States

Event Date/Time: Apr 25, 2013 / 9:00 am - (PST) End Date/Time: Apr 26, 2013 / 6:00 pm - (PST)
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Description

 

Summary:  No compliance professional needs to be told how important an effective complaint handling system is. If you have not put it in place, it means only one thing –you become the FDA’s practice target.

Worried about how to put a complaint handling system that really works? Leave those behind you, for GlobalCompliancePanel is organizing a two-day seminar that addresses this need. This is a fabulous opportunity for you to show that you can have an effective complaint handling system in place, which ensures not only that you have a proper Medical Device Reporting (MDR) system; you need spend no more sleepless nights over an FDA visit or a complaint from a customer, both of which can ruin your business.

Full Seminar Description

In a nutshell; this seminar from GlobalCompliancePanel, entitled “Effective Complaint Handling, Medical Device Reporting and Recalls”, is a sure-shot way to being on the road to having a double-edged complaint handling system. On the one hand, it ensures that you have a way to address complaint handling. This is a means to know what your customer expects. Analyzing and addressing complaints from your customers is a sine qua non for quality.

On the other; by having such a system in place, you ensure that the FDA cannot issue notices to your business. At this two-day event, the speaker, David R. Dills,a Regulatory & Compliance Consultant with a quarter century of experience, will let you know exactly what it takes to be compliant with your complaint handling mechanism. Given the invaluable lesson this seminar imparts; all that it costs you is $1,295.00. And wait…we have fabulous discounts for group participation:

o   Send two attendees: Get a discount of 10%

o   Send three to six attendees: Get a grand discount of 20%

o   Send seven to 10 attendees: Get a great discount of 25%

o   Send more than 10 attendees: Get a whopping discount of 30%.

    Attend this intensive course and you’ll learn how to …
  1. Understand that although FDA does not specify a standard complaint handling system, the requirements do specify certain actions that shall be included in any system
  2. Grasp and comprehend the definitions and elements of the regulatory requirements for Complaint Handling, Medical Device Reporting and handling of Recalls
  3. All personnel who deal with customers, or who may receive a complaint call, must be trained in the proper routing/handling of complaints
  4. Provide information about FDA's Medical Device Reporting (MDR) regulation and the Voluntary Reporting program called MedWatch
  5. Introduce you Medical Device Reporting and to help you better understand the process and benefits of Voluntary Reporting and responsibilities
  6. Latest Amendments to the MDR Regulation to Implement FDAMA Changes
  7. To Recall or Not to Recall: Issues to consider regarding whether a Field Action is required
  8. Determine when a recall is required and how to manage a recall, who must report, when to report, what to report, where to report, recordkeeping requirements, FDA regulatory authority, references and guidance
  9. Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
  10. Review and discuss pain points, challenges and solutions
Conference Agenda

DAY ONE

Lecture 1: Complaint Handling:

Lecture 2: Medical Device Reporting

Lecture 3: Exercise and Recap of Day 1

DAY TWO

Lecture 4: Medical Device Reporting

Lecture 5: Recalls

Lecture 6: Exercise and Recap of Day 2

Please note the registration will be closed two days (48 hours) prior to the start date of the seminar.

Call our representative on 1800 447 9407 to have your seats confirmed.

Limited seating, bookings essential!

Price: $1,295.00

Location: San Francisco, CA | April 25th & 25th, 2013 (Thursday & Friday)

Venue : Hilton San Francisco Fisherman's Wharf  2620 Jones Street, San Francisco, California, 94133, USA

From 9 am to 6 pm PDT at Hilton San Francisco Fisherman's Wharf 

 

Contact Information: Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

GlobalCompliancePanel

NetZealous LLC

NetZealous LLC, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

 

 

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GlobalCompliancePanel