Browsing Category Upcoming Events

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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Category : Upcoming Events

The Hitchhiker’s Guide to 483s and Warning Letters – FDA Compliance Trends, Response and Prevention |Oct. 15, 2015, 1 PM EDT | Bazigos

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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Category : Upcoming Events

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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Category : Upcoming Events

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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Category : Upcoming Events

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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Category : Upcoming Events

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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Category : Upcoming Events

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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Category : Upcoming Events

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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Category : Upcoming Events

How to Translate Academic and Discovery Assays Into GLP-Compliant Assays | Nov. 6, 2013, 2 PM EST | Graham

Background This 1-hr Expertbriefings.com Webinar will help you deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.  While academic research needs only to be novel, interesting and scientifically sound to be published, there may be gaps in the known information about [...]

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Category : Upcoming Events

What FDA Expects From You During Design Control Inspections | Oct. 30, 2013, 2 PM EST | Moore

This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined. Why Should You Attend Many companies are confident that [...]

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Category : Upcoming Events

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