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Why is FDA at my facility, and what do I do during an inspection?

in IFSQN Events Calendar
Added by Harshit Choudhary, 17 Jul 2013

Taking place 26 Sep 2013 through 27 Sep 2013 (Ranged Event)

Harshit Choudhary

Logo URL
Event Organizer Compliance Online
Contact Name Harshit Choudhary
Contact Number +1-888-717-2436

Event Category Seminar, Training Course
Event State/City Cambridge, MA
Event Country USA
Cost of Attendance $1,899.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/seminar?product_id=80075SEM&channel=am_IFSQN

Event Description

Thursday, September 26, 2013, 8:30 AM to 5:00 PM EDT and Friday, September 27, 2013, 8:30 am to 4:30 PM EDT, Courtyard Marriott Boston - Cambridge, MA

Course Description:

This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.

This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records. We cover do’s and don’ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. We provide tips for Executive Management/CEO’s, Production area staff, Reception Area staff and what each group needs to know during an inspection. The session includes real life inspection scenarios/case studies. Participants are given real life FDA inspection scenarios and are asked to discuss how they would handle each situation. Feedback is given on how to best handle each situation and scenario. This is one of our most popular training sessions!

Learning Objectives:

If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
  • Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.
  • What to do when FDA knocks – step by step instructions to handle inspections.
  • How to handle day by day inspection scenarios?
  • What is a front room and back room? Do you need one?
  • Runners and Scribes? What do they do?
  • Are your SME’s the right people, and are they ready/right for the job?
  • Why responses to 483’s and Warning Letters are critical?
  • Steps for responding to 483’s and Warning Letters.
Who will Benefit:

Industries Positions/Titles Types of facilities:
  • FDA regulated Industries
    • Medical Device
    • Pharmaceuticals
  • Dietary Supplements
    • Food
    • Med Tech
  • Top and Middle Management
  • Subject Matter Experts (SME)
  • Quality Assurance/management
  • Compliance Management
  • Manufacturing
  • Laboratory
  • Regulatory Personnel
  • Manufacturing facilities
  • Private label and contract manufacturing facilities
  • Distributors, warehouses
  • Own label distributors, private label distributors
  • Packers, Labelers
  • Ingredient suppliers
  • Laboratories
  • Importers
Meet Your Instructors:

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Martina LaGrange
Principal, FDA Compliance Group LLC

Ms. Martina LaGrange began her career in Seattle, WA as an FDA Field Investigator. She moved back home to Denver, CO in 1996 where she completed her 14 year career with the FDA as a Medical Device Specialist.

Ms. LaGrange performed medical device, dietary supplement, pharmaceutical and clinical investigator inspections both domestically and internationally. She inspected some of the world's largest manufacturers, with 75% of inspections resulting in the issuance of a Warning Letter. She was the lead investigator on several injunction recommendations.

Ms. LaGrange was a member of the Quality System Inspection Technique (QSIT) Reengineering Team. She assisted in creating QSIT Training CD-ROM and QSIT CD Exam. She assisted in developing QSIT Training for FDA managers and compliance officers, and was a presenter on the 7/00 LIVE video downlink that trained FDA managers and compliance officers nationwide. She received Vice President Gore's Government Hammer Award for her accomplishments in the device arena. She was also part of the Medical Device EIR (Establishment Inspection Report) Workgroup, created to harmonize FDA's inspectional reports in accordance with the Mutual Recognition Agreement (MRA). She provided classroom training to FDA employees European Union authorities, Colorado Department of Health and Environment, trade groups, and professional societies.

Ms. LaGrange has been consulting in the medical device, dietary supplement, pharmaceutical and clinical investigator areas since 2003. She continues to assist FDA regulated companies in gaining compliance with the FDA regulations. Her focus includes gap analysis, quality control reviews, mock FDA audits, training, SOP development, MDR and Adverse Event Reporting.

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Shelly Maifarth, RAC
Principal, FDA Compliance Group LLC

Ms. Maifarth began her career with FDA as an investigator and microbiologist in Dallas and Denver Districts from 1972 to 1984, then served as an FDA Compliance Officer in Denver's District Office for more than 22 years. As a compliance officer, she has significant experience in the medical device, dietary supplement, food, and pharmaceutical areas. She has conducted training, reviewed quality systems and provided guidance on quality, labeling and compliance issues. Ms. Maifarth provided technical assistance and guidance to investigators and analysts within Denver District, and to state, local, and other federal agencies, including Customs (CBP), EPA, and CDC.

As the senior Compliance Officer in the Denver District Office, Ms. Maifarth received the most complex cases to determine if a company was in compliance with FDA laws, regulations and current policy. These cases were in the areas of medical device cGMPS/labeling/510(k)/PMA, dietary supplement labeling, pharmaceutical GMPS/labeling/new drug, seafood and juice HACCP, and food sanitation and labeling. She successfully completed numerous regulatory actions to bring firms and products into compliance. These actions included Warning Letters, Regulatory Letters, Seizures, Injunctions, Prosecutions, Inspection Warrants, License Suspensions and License Revocations. She provided guidance to assist these companies to come into compliance after these FDA actions.

Ms. Maifarth served as a member of the Expert Panel for National Compliance Officers Law Course, a member of Cadre and Trainer for National Compliance Law Clerk Course, and has provided training for Regulatory Affairs Professional Society (RAPS) on current FDA compliance policies on dietary supplements, drugs and medical devices.

Since beginning her career as a consultant, she has worked extensively with medical device and dietary supplement industries to assist them in achieving compliance with the requirements of FDA laws and regulations. She has coordinated meetings and successfully interacted with FDA on behalf of client firms at the Denver District, FDA Headquarters, and other district offices. She effectively coordinates communication with FDA post-audit, writes 483 responses on behalf of client firms to the FDA, and coordinates any subsequent follow-up.

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