2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare

By: David R. Dills, Global Regulatory Affairs & Compliance Consultant and President, NovaQual.
Product code: SEM35
Location 1: San Diego CA Mar 14 - 15

Description

Course has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.

The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises.

The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.

Here are some take away Note 

1. “WCS public seminars are designed to be very interactive, address case studies and group exercises where applicable with top industry leaders who share their knowledge in an enthusiastic, interactive manner. We offer many training options to meet your particular learning needs. We offer face-to-face classroom training as well as the flexibility of on-site learning options at your company.”

2. “We add value to training with our established authority in the life sciences industry. Our regional experts and trainers speak your language. They also understand local knowledge needs, ensuring a tailored program that matches your requirements.”

3. WCS provides international quality, compliance and regulatory training courses. We offer public training classes and private in-house courses. Our industry and regulatory experts work with you to deliver flexible, modular and professionally accredited training.”

4. “Maximize learning but benchmarking what other companies are doing and following the latest global trends during the seminar. “

5. “We want to help the pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training that is effective and timely.”

Areas Covered

•        FDA’s Inspectional Authority and History
•        FDA Inspection Program Overview
•        Key factors for a successful FDA inspection
•        Quality System Readiness
•        Organization Readiness
•        Manage Inspection Outcomes
•        Information and Documentation
•        How a firm should prepare for an FDA inspection?
•        Ways to train employees in view of the inspection
•        How to ensure that required documentation is in place
•        How to interact with the investigator-DO's and DON'T's
•        What companies should do when the inspection ends
•        How to reply to 483's and warning letters

Who will Benefit

•        Auditors
•        Clinical Affairs
•        Compliance Officer
•        Compliance Specialist
•        Consultants
•        Distributors/Authorized Representatives
•        Engineering/Technical Services
•        Executive Management
•        Laboratory
•        Legal Counsel
•        Marketing & Sales
•        Operations/Manufacturing
•        QC/QC
•        Quality Assurance Management
•        Regulatory Affairs Management
•        Regulatory Affairs Specialist

Learning Objectives

This seminar will provide an overview and in-depth snapshot of the entire process for preparing for and managing and FDA inspection and external regulatory inspections. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspection process from preparing for the inspections, during the inspections and post-inspection responsibilities.

Course Outline:

09:00 AM - 05:00 PM

•        FDA’s Inspectional Authority and History
•        FDA Inspection Program Overview
•        Key factors for a successful FDA inspection
•        Quality System Readiness
•        Organization Readiness
•        Manage Inspection Outcomes
•        Information and Documentation
•        How a firm should prepare for an FDA inspection?
•        Ways to train employees in view of the inspection
•        How to ensure that required documentation is in place
•        How to interact with the investigator-DO's and DON'T's
•        What companies should do when the inspection ends
•        How to reply to 483's and warning letters

 

09:00 AM - 05:00 PM

•        Legal implications of non-compliance
•        Why inspections are conducted and by what statutory authority
•        The emphasis on systems-based inspections... and the IOM and other crucial FDA reference documents
•        What is subject to FDA purview and what's off-limits
•        Understand and apply the do's and don'ts and comprehend that preparation is the key to success
•        What are the prohibited "Acts" and the enforcement categories that you need to deal with?
•        What you need to know and do to prepare for, during and even after the inspection... and why your inspection response team is key
•        The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
•        How to respond to findings and facilitating the documentation and remediation process... and reaching final closure
•        Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development
•        Exit Interview
•        FDA interviewing employees and personnel
•        Mock Inspections and Mock Audits and why role playing is important

 

speaker

David R. DillsGlobal Regulatory Affairs & Compliance Consultant and President, NovaQual

David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts regulatory and compliance assessments. He leads and directs all activities for the product registration and approval process and working with the regulatory agencies in Asia Pacific (APAC), EU, Latin America (LATAM), Middle East, EMEA, including but not limited to FDA, European Medicines Agency, MHRH, ANVISA, MOH, PMDA, MOH, TFDA, MDCO, CFDA, TGA, Health Canada and others regarding multi-country product registrations and licensing. Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities while developing strategies for governmental approval to introduce new products to market. He conducts communications with regulatory authorities and company representatives while executing an effective path to approval and helping with GxP compliance strategies in global markets. 

14-March-2018 To 15-March-2018 San Diego CA
Seminar One Registration
$ 1295



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Homewood Suites by Hilton San Diego-Del Mar
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Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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15-20 minutes product demo during the live session

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