FDA OPQ Releases 2024 State of Pharmaceutical Quality Report: Key Trends for Pharma Professionals
FDA’s Office of Pharmaceutical Quality (OPQ) has published its seventh annual State of Pharmaceutical Quality report for FY2024, providing an in-depth analysis of drug manufacturing oversight, inspection trends, and compliance patterns. Spanning October 2023 through September 2024, the report identifies emerging quality risks, evolving regulatory enforcement trends, and areas of potential concern for industry quality […]
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UPCOMING WEBINAR Complaint Handling and Post Market Management – How to Comply with Global Regulatory Requirements
Summer 2025, Date TBD Jackelyn Rodriguez, President Monarch Quality Systems Solutions FDA investigators consider how a medical device company handles complaints to be an important indicator of a manufacturer’s overall state of control of their Quality System— if the complaint and MDR systems are not in a “state of control,” chances are the rest of […]
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How to Survive Your Next FDA Inspection – July 15, 2025, 2 PM EDT
How The Quality Manager Gets Fired, aka The $50,000 Compliance Mistake: You’ll learn about this in the Webinar below, but here’s a hint – You have 15 days to respond to a 483, or else! Miss the deadline, and your FDA 483 response is for naught! It sounds obvious, but this huge costly mistake […]
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GotoWebinar: CGMP’s DHF, DMR, DHR, and EU’s Technical Documentation – July 30, 1 PM EDT – Lincoln
One of our most popular webinars, updated with the latest FDA and EU requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU’s CE-marking documentation is a requirement — the Technical FiIe or Design […]
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Damage Control! How to Handle an FDA Drug or Device Recall – June 12, 2 PM EDT – Moore
In June, you have the unique opportunity to learn about how to avoid and manage FDA recalls from Dennis Moore, a former Level II FDA Investigator in our 60-minute GotoWebinar. The question of whether Food and Drug Administration (FDA) regulated products must be reported to the agency comes down to the type of product and […]
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How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques, Aug. 1, 2025, 2 PM EST | Moore
What You Will Learn In This cGMP Inspection Webinar FDA is more vigilant and aggressive than ever before with its cGMP inspection procedures. FDA is quick, visible and vigilant. In this comprehensive Webinar by Dennis Moore, Chief Technical Expert and Managing Partner of Auk Technical Services LTD, you will learn absolutely everything you need […]
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GotoWebinar: Verification and Validation Planning and Execution – July 24, 1 PM EDT – Lincoln
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V […]
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GotoWebinar: Bullet-Proof Closed-Loop CAPA, Failure Investigation, and Root Cause Analysis – June 5 – Lincoln
A company’s CAPA System is supposed to be a major tool in resolving product complaint, non-conformance, and focusing OOS failure investigations, and hazard analysis / risk management and mitigation activities. As such it is the core component of a successful CGMPÂ quality management system, a proactive driver of improvement, and expected by Regulatory Bodies. Why […]
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FDA Essential: A Strong cGMP Quality Agreement| June 24, 2019, MINSK
In his 10th appearance in this highly praised webinar (see feedback below), discover a potential table of contents for your cGMP or GCP quality agreement, why you must use FDA defined terms where they exist. Learn the obligations for all stakeholders under a quality agreement, how to develop your quality agreement that meets cGMP guidelines, […]
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FDA Recall Chief Update – How to Design a Bulletproof Product Recall Strategy | June 6, 2019, 2 PM EDT | Hoffman
Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements Recall compliance is critical to the continued survival of all device manufacturers. FDAÂ is continuing its efforts to issue numerous Warning Letters and serious enforcement actions, including criminal and civil penalties levied on companies that fail to properly report events and […]
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