Why is FDA at my facility, and what do I do during an inspection? : 2-day In-person Seminar
Shelly Maifarth, Principal, FDA Compliance Group LLC
Coming soon.. Please contact customer care for new schedule
This two day interactive course will prepare firms for a quick, productive, and efficient FDA inspection. It includes 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.
The session includes real life inspection scenarios/case studies and templates.
Day one of the seminar will begin 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, instructor will 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. On day two, instructor will focus on do’s and don’ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. This course also provides tips for executive management/CEO’s, production area staff, reception area staff and what each group needs to know during an inspection.
Participants will be getting real life FDA inspection scenarios and will be asked to discuss how they would handle each situation. Feedback will be given on how to best handle each situation and scenario. This is one of our most popular training sessions!
Seminar instructor Shelly Maifarth is an ex-FDA official having more than 30 years of experience working with the FDA as an investigator, microbiologist and as a compliance officer.
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:
||Types of facilities:
- FDA regulated Industries
- Medical Device
- Food & Dietary Supplements
- Med Tech
- Top and Middle Management
- Subject Matter Experts (SME)
- Quality Assurance/management
- Compliance Management
- Regulatory Personnel
- Manufacturing facilities
- Private label and contract manufacturing facilities
- Distributors, warehouses
- Own label distributors, private label distributors
- Packers, Labelers
- Ingredient suppliers
|Day One (8.30AM – 5.00PM)
||Day Two (8.30AM – 5.00PM)
FDA Law and Inspection Training
- FDA Management and General Training
- Legal Obligations
- FD&C Act, § 704(a)(1), Right to Inspect
- Case Law- Real life examples
- Section 305 Notices
- Consent Decree
- Dis-engorgement penalty
- Regulatory Sanctions used by FDA
- Written Notices
- Judicial Action
- Prosecution (fines, jail)
- Administrative Action
- Prohibited Acts
- Interstate commerce
- Prosecution (fines, jail)
- Civil vs. Criminal
- Management Responsibility from FDA’s view
- Management with Executive Responsibility defined
- Duty, Power, Responsibility
- Front Room Back Room
- Your FDA Inspection Team
- Inspection Team Roles
- Assigning jobs on the Inspection Team
- FDA Inspection SOP
- Initial FDA Meeting
- Scribes-what are they – what do they do?
- Runners- what are they- what do they do?
- Front Room/Back Room
- Putting it all together
SME training, 483/Warning Letter Response
- SME Training
- Basic Ground Rules for everyone
- Role of the SME
- What is an SME?
- SME Characteristics
- How to choose effective SMEs
- Off-site SMEs
- SME’s Should:
- Utilize Subject Matter Experts (SMEs)
- FDA Interviews
- predetermined roles
- How to understand and answer FDA questions
- Should you use props!
- What does your Facilitator do?
- How to get the best out of the inspection
- Say NO to…
- Do’s and Don’ts
- Replying to 483s and Warning Letters
- General Points to Consider
- FDA 483 Responses
- Warning Letter Responses
- What you must know about both responses
- Hard copy or via the internet?
- Specific and Systemic Corrections
- Templates to consider
- Make sure…
- The Response
- Response Cover Letter
- Who Signs
- Response Body
- Let’s not forget
- When and How to do updates
* This training will not delve into clinical inspection issues.
Meet Your Instructor
||Shelly Maifarth, RAC
Principal, FDA Compliance Group LLC
Shelly 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.
Register by P.O. / Check
Yes, I want to attend "Why is FDA at my facility, and what do I do during an inspection? : 2-day In-person Seminar".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ firstname.lastname@example.org
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
If you wish to partner with us for this event
contact us: email@example.com
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media Partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner to do
- Banner (min 728x90 or 468x60) on the Media Partner website.
- Insertion of the 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 of Media Partner.
- Article on the Magazine and/or Website after the conference.
If you wish to sponsor this event
contact Cruise Webster: firstname.lastname@example.org
call us: (207) 576-4173
It is the official London residence of the Queen and principal workplace of the British monarch. It is located in the City of Westminster. Open for tours during the summer months only, but a must-see sight even if you don't go in.
The London Eye is a giant Ferris wheel situated on the banks of the River Thames in London. The entire structure is 135 meters (443 ft.) tall and the wheel has a diameter of 120 meters (394 ft.). It is the tallest Ferris wheels in Europe and the most popular paid tourist attraction in the UK. London Eye is visited by over 3.5 million people annually.
Tower of London:
Situated just south east of the City, is London's original royal fortress by the Thames. It is over 900 years old, contains the Crown Jewels, guarded by Beefeaters, and is a World Heritage site. It is also considered by many to be the most haunted building in the world. If you are interested in that sort of thing it’s definitely somewhere worth visiting.
Tower Bridge (built 1886–1894) is a combined bascule and suspension bridge in London, over the River Thames. It is close to the Tower of London, from which it takes its name. it has become the iconic symbol of London.
This museum in London is dedicated to human history and culture. Its permanent collection, numbering some eight million works, is among the largest and most comprehensive in existence and originates from all continents, illustrating and documenting the story of human culture from its beginnings to the present.
St Paul’s Cathedral:
St Paul's Cathedral, London, is a Church of England cathedral and seat of the Bishop of London. The cathedral is one of the most famous and most recognizable sights of London, with its dome, framed by the spires of Wren's City churches, dominating the skyline for 300 years. St Paul's Cathedral occupies a significant place in the national identity of the English population.
Madame Tussauds London:
It is a major tourist attraction located in Central London, housed in the former London Planetarium. It is famous for recreating famous people and celebrities, in wax.
The National Gallery is an art museum on Trafalgar Square, London. Founded in 1824, it houses a collection of over 2,300 paintings dating from the mid-13th century to 1900.