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

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Homewood Suites by Hilton San Francisco |

2000 Shoreline Court |

Brisbane CA 94005 | USA

Brisbane, CA 94005

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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

Seminar Coach

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.


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Homewood Suites by Hilton San Francisco |

2000 Shoreline Court |

Brisbane CA 94005 | USA

Brisbane, CA 94005

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