2-Day Virtual Seminar on FDA Inspection Essentials in 2021

Upon completion of this session, you will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.

Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.

Working in a highly regulated industry, we know our firms need to be “inspection-ready” at all times. This is not only to maintain a good rapport with the Regulators, but also as a commitment to quality for our customers, the patients who use our products.

Regulatory inspections should be a time to demonstrate the high level of compliance your firm has to the regulations, and to customer safety and quality. The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.

The inspection management plan should provide for, Response to the arrival of the investigators, Guidance of the inspectors’ activities, Procedure for working with the investigators, and Documentation of the inspection. The management plan or SOP should spell out all of the procedures that you will follow during an investigation. Personnel training is one key variable that should be looked at prior to any inspection. Educate personnel about the inspection process so they can be prepared. Train individuals to interface with FDA investigators. Verify that training has been provided for the personnel on their current job functions, and that supporting records are on file. The goal is to minimize the opportunity for incorrect answers provided to the inspectors, or providing too much information. Have a list of what to do and what not to do when speaking to the inspectors as well.

Why Should You Attend:
You need not dread an FDA inspection if you are adequately prepared. FDA inspections have revealed some trends in recent years. The agency is taking a tougher stand on Quality Systems and using a risk-based approach. Inspectors usually review at least two (2) systems in depth. QA is their number one concern in recent years. They may also look at another system, such as facilities and equipment, materials, production, packaging and labeling or laboratory controls.

FDA does not expect your facility to be perfect. They expect all companies to have some issues. What they really want to see is how you address the problems. The FDA tends to view companies that control these issues to have a high standard of quality. This seminar will help you use the FDA inspection as a learning tool, not as a negative or adversarial experience.

Seminar Objectives:
Learn Pre-planning and preparation activities
Know What to do when the investigator arrives
Know What documents to have ready and on hand
Develop Assignments and responsibilities for the inspection
Be Aware of Inspection Do’s and Don’ts

Who Should Attend:
Quality Control Personnel & Management
Manufacturing Personnel & Management
Senior Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management

SEM2084

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance.

Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.

Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection.

Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

DAY 1 : (12 PM – 4 PM)

FDA Inspections 101
– Unannounced FDA visits – how to prepare and react
– Preparing for FDA audits / PAI preparation – what training should look like for key players
– Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current

Company Preparedness
– How a company can prepare for situations like this – training of SMEs and beyond
– How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

DAY 2 : (12 PM – 4 PM)

Observations and Lessons Learned
– How should a company respond to 483 observations or a warning letter – deadlines, tracking, and closures
– Lesson learned – reviews of the observations and overall inspection experience

Real Life Situations
– Case Scenarios – review of real-life scenarios that you could encounter during inspections

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 at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458
Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through 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 – minus a $300 administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance