2 Day Pharmaceutical, Biopharmaceutical, Biologics and Medical Device FDA Inspection Preparedness and Compliance Seminar (ONLINE EVENT: September 3-4, 2025) - ResearchAndMarkets.com

By: Research and Markets via Business Wire

August 04, 2025 at 08:41 AM EDT

The "FDA Inspection Preparedness and Compliance" training has been added to ResearchAndMarkets.com's offering.

This is a practical, hands-on two-day seminar 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.

Who Should Attend:

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 and for those companies who must establish proven and sustainable GXP Compliance Strategies and risk mitigation strategies when responding to a crisis. 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 and follow up activities with FDA, including:

Executive Management
Regulatory Affairs Management
Regulatory Affairs Specialist
Auditors
QC/QC Management
Compliance Officer
Compliance Specialist
Clinical Affairs
Quality Assurance Management
Marketing & Sales
Laboratory Operations
Distributors/Authorized Representatives
Legal Counsel
Engineering/Technical Services
Operations/Manufacturing
Consultants
Individuals who come in contact with regulatory inspectors
Auditors
Compliance/Regulatory affairs professionals
QA/QC professionals
Manufacturing managers, supervisors & personnel
Project Managers
Regulatory Affairs Management
Regulatory Affairs Specialist
Compliance Officer
Compliance Specialist
Clinical Affairs
Distributors
Legal Counsel

This live training Seminar includes the following for each registered attendee:

A copy of the presentation slides by download
A certificate of participation for attendee training records
Q/A Session
Free Handouts on FDA Inspection

Key Topics Covered:

Day 1

Introductions and Background
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'Ts
What companies should do when the inspection ends
How to reply to 483's and warning letters
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

Day 2

Maintain, or return to, regulatory compliance and minimize downtime
Establish a risk management plan in place to proactively manage compliance, including a crisis-management plan
Set post-inspection deadlines and working closely with FDA's regulatory partners
Compliance remediation is the process of recognizing problems, creating a plan to correct and prevent them from occurring in the future, and executing to that plan to helps with your GxP Compliance Strategy.
Guidance on how to request and conduct PDUFA meetings and expectations for Sponsor-FDA Meetings
Guidance outlining clear recommendations for sponsors and for FDA staff and managers as well for Pre-Submission meetings as expected timeframes for scheduling meetings
Mechanics of requesting any FDA meeting and what you need to know to be successful with communication style, approach and tactics
Prioritize follow-up on warning letters and other enforcement actions
Develop and implement a formal warning letter "close-out" process
Untitled Letter and the Warning Letters
Recent Trends and Enforcement Actions for 2017
Mock Inspections and Mock Audits and why role playing is important

Recap of Day 1 and Day 2

Exercise on Day 2

Interactive Discussions
Review Regulatory and Compliance Documentation
Recent Enforcement Actions for 2017 and Emerging FDA Trends
Classroom Project: Prepare for and Host an FDA Mock Inspection and Prepare Effective Company Response to FDA 483 and/or Warning Letter

Debrief/Adjourn/Wrap-Up

Speakers:

Kelly Thomas

Vice President

Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

For more information about this training visit https://www.researchandmarkets.com/r/u7ae3v

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View source version on businesswire.com: https://www.businesswire.com/news/home/20250804762325/en/

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2 Day Pharmaceutical, Biopharmaceutical, Biologics and Medical Device FDA Inspection Preparedness and Compliance Seminar (ONLINE EVENT: September 3-4, 2025) - ResearchAndMarkets.com

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