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The MSBA's Food Drug & Device Law Section and
LifeScience Alley Present

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Food, Drug & Device Facility Inspections: Lessons from FDA, the Minnesota Department of Agriculture, and Industry

Join us at this interactive event focusing on government inspections, which features a panel of experts, including Cheryl Bigham, Deputy Director, FDA MIN-DO, Katherine Simon, REHS, MDA Inspection Supervisor, and local attorneys. The experts will walk attendees through FDA’s drug, device and food inspection programs, and discuss the ways state food inspectors prepare for inspecting firms, what they look for, and how they expect firms to prepare for and respond to an inspection. Our dynamic speakers will address food, drug and device inspection questions you have such as:

  • What factors determine which firms will be inspected and the frequency of inspection?
  • What training manuals and guides do the agencies use to train inspectors?
  • What regulatory authority are inspections conducted under? What are the limits of authority?
  • Are inspections pre-scheduled or unannounced? What is an FDA-482 (Notice of Inspection)?
  • What records or information should a firm be prepared to supply during an inspection?
  • How should a firm respond during an inspection? What are the do’s and don’t’s?
  • What can a firm do to help the inspection proceed efficiently and expediently?
  • What is the inspector looking for when they are conducting an inspection?
  • Inspectors can’t possibly look at everything – how do they decide what will get looked at?
  • What sort of inspection policy and procedure should we have in place as a firm? How should we prepare?
  • The inspector sampled one of our products – how do they decide what to sample, what to analyze it for and will we get the results? What should we do with the product that has been sampled while we are waiting for the results?
  • Should a firm make corrections on the spot?
  • How is the inspection documented?
  • What should a firm expect after an inspection?
  • What should we do at the end of an inspection when/if the inspector presents an affidavit?
  • What steps should a firm take after an inspection to submit a formal response to an inspection or to correct action items?
  • How should a firm respond to an FDA-483? What about an Untitled Letter or a Warning Letter? What else is in the FDA enforcement armamentarium (e.g., recalls, injunctions)? What are the state’s enforcement options in food facilities?

Speakers:

Cheryl Bigham, Deputy Director, FDA MIN-DO
Cheryl A. Bigham recently became the Deputy District Director of the Food & Drug Administration’s Minneapolis District Office. As the previous Director of Investigations Branch in Minneapolis District for fourteen (14) years she was responsible for routine inspections of manufactured and imported drug, device and food products, complaint investigations, recall audits, and sample collections. Since 1983, Ms. Bigham has served in several capacities within the FDA including Supervisory Investigator in the Milwaukee Resident Post, Consumer Safety Officer in St. Louis and Philadelphia, and as a Chemist in Atlanta, GA. She has also served as Recall Coordinator, Compliance Officer, and Small Business Representative and served a detail as the Special Assistant for the Associate Commissioner for Regulatory Affairs.

Mark Gardner, MBA, JD, DuVal & Associates, P.A.
Mark Gardner is an attorney at DuVal & Associates, P.A., where he counsels companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Mr. Gardner’s practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, and FDA enforcement actions. Prior to his legal career, he worked in product management and sales for three medical device companies over a 10-year span where he focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.

David Graham, JD, Oppenheimer, Wolff & Donnelly, LLP
David Graham is a partner at Oppenheimer, Wolff & Donnelly, LLP where he represents clients in the pharmaceutical, medical device and food industries. His practice focuses on defense litigation, as well as regulatory actions and investigations. Mr. Graham represents clients in multi-district litigation, class actions, and consolidated state court proceedings. He also represents clients in FDA and USDA food labeling, advertising and safety matters.

Katherine Simon, REHS, MDA Inspection Supervisor
Katherine Simon is a Food Inspection Supervisor at the Minnesota Department of Agriculture. Previously, she was an inspector for the Minnesota Department of Agriculture for six years and an inspector for USDA Food Safety Inspection Service. Ms. Simon has extensive experience in inspecting both manufacturing and food facilities. Ms. Simon is a recent graduate of the prestigious International Food Protection Training Institute’s Fellowship program where she focused her research project on the impact of the constitutional licensing exemption for farmers on MDA’s regulation of the produce supply.

2.5 hours of Standard CLE credits applied for.
The event code is 173448.

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Details:

Date:   Friday, November 9, 2012

Time:   8:00 a.m. to 10:30 a.m.

Location:   MSBA Offices, 600 Nicollet Mall, Suite 380, Minneapolis, MN 55402 

Registration and breakfast will begin at 7:30 a.m. The CLE program will start at 8:00 a.m.

Cost:
Food Drug & Device Law Section or LifeScience Alley Member:  $20.00

MSBA Members: Join the Food Drug & Device Law Section and attend this meeting for FREE (You must be a current MSBA member but not a section member. Pay the 12-month section dues and your membership will expire on June 30, 2013.): $28.00

MSBA Member But Not A Food Drug & Device Law Section Member:  $25.00

Not A MSBA or LifeScience Alley Member:  $30.00

Law Students:  Free

Teleconferencing is available. Teleconferencing instructions will be sent by e-mail on Thursday, November 8. Registrations must be received no later than Tuesday, November 6 in order to receive the instructions.

Cancellation Policy:
Refunds will be processed for cancellation requests received in writing on or before noon on the registration deadline. Requests should be directed to the event contact person listed at the bottom of this notice. Cancellation requests received after this time are not eligible for refunds. You may send a colleague in your place if you are unable to join us and the registration deadline has passed.