Browsing 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

Effective Vendor Qualification and Validation of Reagents in a GLP/GMP Laboratory| Oct. 28, 2013, 2 PM EDT | Graham

Background This one hour Expertbriefings.com Webinar will teach you what to look for when it comes to vendor qualification and validation for reagents in a GLP/GMP laboratory. It will teach what to ask for to qualify reagents, whether for completely new purposes or existing uses, and to validate that the reagents are what the manufacturer [...]

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Category : Upcoming Events

How to Ensure FDA Compliance in Developing a Strong Complaints Handling System | Jan. 21, 2014, 2 PM EDT | Lim

Webinar Overview The increasing number of recalls of medical devices and drugs has intensified the focus on ensuring their safety and effectiveness. From both regulatory and business liability perspectives, it is crucial for pharmaceuticals and medical device manufacturers to record, track, and report medical devices and drug-related complaints in a systematic manner. Medical device manufacturers [...]

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Category : Upcoming Events

The Essentials of Cleaning Validation for Pharmaceutical Manufacturers | Nov. 15, 2 PM EDT | Phillips

Cleaning validation is a timely topic that should concern all pharmaceutical manufacturers and subcontractors. Surface contamination and critical cleaning must be understood in order to have an effective, well thought out cleaning validation program. This webinar will cover the concepts of critical cleaning, FDA requirements and cleaning validation. Attention will be paid to understanding cleaning [...]

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Category : Upcoming Events

FDA-Compliant Strategic Software Validation Planning for Senior Management | Oct. 23, 2013, 2 PM EDT | Fuller

This new Webinar on FDA software validation training will detail how you as a senior manager should approach software validation so you will be able to easily satisfy new FDA compliance initiatives. In recent years, FDA has put in place many new enforcement initiatives that affect software validation, and will also affect your regulatory risk [...]

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Category : Upcoming Events

Understand FDA’s Latest Thinking on Industry cGMPs for Phase 1 INDs| Oct. 25, 2013, 2 PM EDT | Whestone

This new Webinar, presented by a former FDA investigator, will give you a unique, insider view on the new FDA cGMP guidance and regulations for Phase 1 INDs. Background FDA has issued a draft guidance document outlining a suggested approach to complying with current GMP  requirements for drugs intended solely in Phase 1 studies.With this [...]

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Category : Upcoming Events

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