Avoiding Warning Letter Disasters With a Strong cGMP Quality Agreement| Dec. 4, 2018, 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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How to Design an Effective CAPA Program, and Avoid FDA Scrutiny| Nov. 1, 2018, 2 PM EDT | Cook
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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How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques, Nov. 14, 2018, 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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Avoid FDA 483 Observations Through Effective Investigation and CAPA Procedures | Nov. 16, 2018, 1 PM EST | Lanese
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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The Hitchhiker’s Guide to 483s and Warning Letters – Oct. 20, 2018
In this light, entertaining but rigorous Webinar by Angela Bazigos, CEO Touchstone Technologies, presenter of our other excellent webinar on writing FDA compliant SOPs, you will learn the very latest in FDA compliance trends, how to respond to an FDA 483 and warning letter, and how to prevent them from occurring at all. Any [...]
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The Hitchhiker’s Guide to 483s and Warning Letters – FDA Compliance Trends, Response and Prevention |Oct. 15, 2015, 1 PM EDT | Bazigos
In this light, entertaining but rigorous Webinar by Angela Bazigos, CEO Touchstone Technologies, presenter of our other excellent webinar on writing FDA compliant SOPs, you will learn the very latest in FDA compliance trends, how to respond to an FDA 483 and warning letter, and how to prevent them from occurring at all. Any [...]
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Top Compliance Trends for 483s and Warning Letters for 2014 | Jan. 15 2015, 2 PM EST| Moore
Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements From the Webinar – Move to Kansas? Let’s just put it this way: There are FDA District Offices that make a major hobby out of writing warning letters (LA- we’re looking at you), and other offices that send out a warning [...]
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Impact of FDASIA – New Quality Agreements Guideline, and Compliance Program Guide Sec. 490.100 for Process Validation | Aug. 7, 2014, 2 PM EST | Medina
FDASIA is legislation signed into law on July 9, 2012 that amends several drug and device provisions of the FD&C Act. By specifically addressing Drug Supply Chain, it enhances FDA’s authority over a manufacturer’s supply chain while strengthening FDA’sadulteration laws. In addition, FDASIA increases FDA’s authority over registered and unregistered foreign firms. Most significantly, this [...]
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Essential Tips for Outsourcing 21 CFR 11 Compliance at Critical Suppliers| July 22, 2014, 2-3:30 PM EST | Avellanet
Why You Should Attend FDA’s mantra for the past few years has been “more supplier scrutiny and more enforcement of Part 11.” Between the rise of cloud computing, more outsourcing, and growing use of contract manufacturers and outsourced clinical trials, pharma and device firms are stuck between FDA’s special enforcement and rapidly changing business models. [...]
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