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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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 CGMP quality management system, a proactive driver of improvement, and expected by Regulatory Bodies. Why […]
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GotoWebinar: CGMP’s DHF, DMR, DHR, and EU’s Technical Documentation – June 11, 2019, 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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How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques, June 11, 2019, 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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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. FDA 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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How to Design an Effective CAPA Program, and Avoid FDA Scrutiny| June 5 – Lincoln
This 60 minute Webinar on CAPA training will give you insights into FDA’s new focus on CAPA effectiveness, and how to effectively manage your CAPA program to avoid an FDA warning letter or 483. Why Attend? The most important area audited by the FDA is CAPA. FDA views this system as an indicator for the […]
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Avoid FDA 483 Observations Through Effective Investigation and CAPA Procedures |
This Expertbriefings.com Webinar will discuss the FDA expectation for thorough and the complete investigation of deviations and follow-up. This is an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations. Why Should You Attend: Recent Consent Decrees have included requirements that the firm develop and implement systems that […]
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Effective Laboratory Controls – How To Prepare for a System-Based FDA Audit | November 2, 2018, 2 PM EDT | Lanese
This popular Webinar on drug laboratory controls focuses on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this 90 minute Webinar, you will fully understand how to prepare your laboratory for FDA. Why should you attend? We notice that many […]
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