
Perella Weinberg Hires Veteran Greenhill Dealmaker David Wyles
Wyles is set to join Perella as a London-based partner after a period of gardening leave, a spokesperson for the bank confirmed in response to Bloomberg News queries. He previously helped run Greenhill's business in Europe, the Middle East and Africa.
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2 Day Pharmaceutical, Biopharmaceutical, Biologics and Medical Device FDA Inspection Preparedness and Compliance Seminar (ONLINE EVENT: September 3-4, 2025)
DUBLIN--(BUSINESS WIRE)--Aug 4, 2025-- The 'FDA Inspection Preparedness and Compliance' training has been added to 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: This live training Seminar includes the following for each registered attendee: Key Topics Covered: Day 1 Day 2 Recap of Day 1 and Day 2 Exercise on Day 2 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 About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: EDUCATION MEDICAL DEVICES HEALTH PHARMACEUTICAL TRAINING BIOTECHNOLOGY SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 08/04/2025 08:41 AM/DISC: 08/04/2025 08:41 AM