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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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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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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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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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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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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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 GMPÂ requirements for drugs intended solely in Phase 1 studies.With this […]
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Qualify Your Vendors – Designing and Implementing a cGMP-Compliant Vendor Program| Oct. 24, 2013, 2 PM EDT | Graham
This new Webinar will provide you with exact details of what you need to do to design a fully cGMP compliant vendor program for your pharmaceutical or medical device supply chain. You will learn how to implement it throughout your company, how to deal with all documentation issues, and how to communicate efficiently with your […]
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How to Bulletproof Your 510(k) Submission: Best Practices for Preparation, Submission and Clearance | Nov. 7, 2013, 2 PM EDT | Lim
This Webinar will tell you precisely how to prepare and submit a traditional premarket notification 510(k) for successful FDA clearance. The premarket notification 510(k) is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). If FDA changes its ruling on certain types of medical devices, such as tanning beds which […]
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Update on Tanning Beds and the FDA 510(k) Submission Process, Contents and Format | Sept 10, 2013 | Lim
Exclusive cGMP, FDA and 510(k) Compliance News FDA in May 2013 came out with a proposed order that if it is finalized, is going to reclassify tanning beds and related sunlamp products as class II medical devices, and they will require a label that will warn people under 18 to not use such products. This […]
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