How To Survive Your Next FDA Inspection – Survival Guide Tips and Techniques – Oct. 2, 2015, 2 PM EST | Moore
Webinar Preview! 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 [...]
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Dangerous Documents – Avoiding Land Mines in Your Emails and Documents| Oct. 7, 2015, 2 PM EST
Dangerous Documents: Avoiding Land Mines in Your Emails and Documents is a absolutely unique 90 minute webinar with former DOJ prosecutor Nancy Singer – where you will discover the potential consequences of writing emails and other documents that are inappropriate. After this in person, event, your employees will be motivated to create correspondence that, if subpoenaed, [...]
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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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eTMFs and Investigator Portals: Emerging Best Practices in Light of Recent EMA Guidance | April 24, 2014, 2 PM EDT | O’Connor
The European Medicines Agency this year produced a draft guideline paper titled “Reflections paper on GCP compliance in relation to trial master files (paper and/or electronic) for management, audit and inspection of clinical trials.” The emerging guidance provides unfolding regulator insight into the use of web technology to manage globally distributed clinical sponsor to site [...]
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How to Design an Effective CAPA Program, and Avoid FDA Scrutiny| Jan. 16, 2014, 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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US, EU and Japan cGMP Requirements: Practical ICH Differences, Regulatory Inspection Focus | Jan 8, 2014, 1 PM EST | Russell
This is a unique, three hour Webinar that will help you to gain a complete grasp of ICH cGMPs, as well as the nuances and the differences between regulatory requirements in the United States, the EU and Japan. After this event, you will be fully prepared for cGMP regulatory inspections in those countries. Why You [...]
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Product Life-cycle Management Program for Process Validation: FDA’s Current Expectations | Oct. 25, 2013, 2 PM EST | Medina
Process Validation and on-going verification is a continuous process calling for a planned life-cycle management program to ensure that the manufacturing process remains capable and in a state of control. This is achieved through the systematic compilation, analysis, and assessment of process-related data, anddeep understanding of actions taken during a product’s manufacturing history.
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