FDA Inspection Preparedness And Compliance Seminar  (ONLINE EVENT: December 3-4, 2024/ON-DEMAND)
FDA Inspection Preparedness And Compliance Seminar  (ONLINE EVENT: December 3-4, 2024/ON-DEMAND) . (MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "FDA Inspection Preparedness and Compliance" training has been added to  ResearchAndMarkets.com's  offering. This is a ...
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(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "FDA Inspection Preparedness and Compliance" training has been added to ResearchAndMarkets.com's offering.

This is a practical, hands-on two-day 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

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'T's

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

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2024-11-08
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(MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "FDA Inspection Preparedness and Compliance" training has been added to  ResearchAndMarkets.com's  offering. This is a ...
FDA Inspection Preparedness And Compliance Seminar  (ONLINE EVENT: December 3-4, 2024/ON-DEMAND)