$685 – $2,285

One Day Seminar: "Effective Responses to FDA-483 forms and Warning Letters...

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Homewood Suites by Hilton San Francisco Airport-North

2000 Shoreline Court

Brisbane, CA 94005

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Description

Description

An Interative Workshop Presented BY WCS & J. Lawrence Stevens, RAC

Course “Effective Responses to FDA-483 forms and Warning Letters on Quality Systems“ has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

Each attendee will receive 1-Day workshop materials by the speaker. Seminar Also Includes Certificate,
Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS

FDA has increasingly issued FDA-483 Observations and then turned to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA is including in FDA-483’s and Warning Letters makes mere compliance not sufficient, but rather the company must have state of the art quality systems. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable to FDA as you may have not done it up to the FDA requirements. Effective responses to FDA-483 Observations can prevent a Warning Letter, and effective responses to Warning Letters can prevent the famous “Sign or Sue Letter” from FDA (the infamous consent decree).

In this seminar, we will discuss the kinds of issues FDA is citing on FDA483’s and in Warning Letters relating to quality system deficiencies. We will discuss inadequate responses and the FDA consequences for such. We will discuss how to prepare a response FDA will consider acceptable and prevent further FDA actions.

Finally, we will discuss how to establish quality systems that will be acceptable to FDA and avoid FDA-483’a and Warning Letters.

Your instructor has held almost every field position within FDA during his 21-year career with FDA, Investigator, Supervisory Investigator, Compliance Officer, Director of Import Operations, Acting Director of Compliance and Acting District Director. He also has over 18 years experience in the Medical Device industry rising from an RA Manager to being a Vice President of RA/QA/Clinical for major class 3 device manufacturers.


Areas Covered

---- Become familiar with issues that are in FDA 483’s and Warning Letters
---- Know what kinds of response will not be acceptable to FDA
---- Know how to effectively respond to an FDA 483 or Warning Letter
---- Know what kinds of company actions can avoid Warning Letters
---- Know how to negotiate with FDA to effectively close Warning Letters



Who will Benefit

--- VP’s
--- Directors
--- Managers of Regulatory Affairs,
--- Quality Assurance.
--- Internal GMP Auditors,
--- Consultants who assist firms with FDA 483 response and Warning Letter remediation.


Learning Objectives

FDA has increasingly issued FDA-483 Observations and then turned to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA is including in FDA-483’s and Warning Letters makes mere compliance not sufficient, but rather the company must have state of the art quality systems. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable


Course Outline:

Seminar Agenda

8:30 AM - Opening – Introductions

8:45 AM - Seminar Goals and topics to be discusses.

9:00 AM - FDA’s legal authority and how they use it. The FDA Inspection, Legal Actions

10:30 AM - Break

10: 45 AM - The FDA-483, What it is, and how to handle it.

12:00 PM - Lunch

1:00 PM - FDA Warning Letters Why are they issued, how are the used, how to respond

1:45 Participant Exercise – Creating Effective Response.

Create responses to typical FDA-483 Observations and Warning Letter Citations

2:30 Break

2:45 - Review and critique participants responses.

4:00 PM Summary of the day, Questions & Answers

4:30 PM Adjourn



Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer


This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered. Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.



“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals



“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.



“Great session. I learned a lot” Chief HR Professional"

“Wow! I had an opportunity to attend the HR audit workshop. It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager



Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


speaker

Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou.


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Benefits of enrolling for Media Partner

Your company Logo on all the mailings before and after the event.

Get 10% discount to media partner's subscribers.

Publish your Logo and company data on the event website.

Publish your Logo on the conference material distributed during the conference.

Media Partner’s brochure distributed along with conference material


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MEDIA PARTNERS WORK TO DO

Publish Banner on the Media Partner website.

Insertion of the WCS event in the event calendar, both printed and/or online.

Announcement article of the conference on the Magazine and/or Website.

Dedicated email blast to all subscribers

Sponsors

Top Sponsors for WCS - World Compliance Seminars


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If you wish to sponsor our event

Please contact us:

partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


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$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases

Listing in monthly Community Leader newsletter sent to over 50,000 users.

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


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$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases

Listing in monthly Community Leader newsletter sent to over 50,000 users.

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session



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speaker

J. Lawrence StevensSenior Regulatory and Quality Consultant at The FDA Group, LLC

Mr. J Lawrence Stevens has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also Mr. Larry has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Mr. J Lawrence has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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Date and Time

Location

Homewood Suites by Hilton San Francisco Airport-North

2000 Shoreline Court

Brisbane, CA 94005

View Map

Refund Policy

No Refunds

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