Recorded Webinars
All recorded webinars may be purchased with a major credit card. After paying you can download the webinar, reference materials and toolkit items, or you may request a CD to be shipped. Digital downloads are available immediately; please allow up to 10 business days for CDs to be mailed.
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Bulletproof Yourself against FDA Enforcement
Learn what FDA inspectors are being trained to look for ... and why. Develop an action plan to handle and follow-up from the new inspectional tactics agency inspectors are using. Based on discussions and interviews with FDA officials responsible for training agency inspectors. Includes templates, checklists, and reference materials to speed implementation.
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Data Quality & Record Integrity in Regulatory Submissions – NDA, ANDA, BLA, 510(k)
1 of every 3 submissions ends in delay or denial due entirely to data quality problems. This recorded seminar, based on interviews and discussions with FDA officials, gives you the exact questions FDA submission reviewers ask of your nonclinical and clinical data. You will not find this information in any FDA guidance document. Seminar toolkit includes dozens of documents, checklists and reference material to ease implementation of this expert advice.
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FDA Expectations of Senior Management - Quality System Oversight
The FDA is increasing its scrutiny and prosecution of corporate executives. The goal: "ensure accountability at the top." So how can you avoid risking your company and your reputation? Designed exclusively for senior management, this recorded seminar is full of key recommendations and reference materials for quick & easy implementation. Every time it's held, it's sold-out - so get the recording today. Loaded with practical tips, costs analyses, and steps to demonstrate effective oversight and leadership.
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FDA Records Retention Requirements – GLP, GCP, GMP, QSR
Learn how to maintain the right records for the right length of time to minimize risk, liability, and cost while meeting FDA expectations. Get a 9-page listing of required FDA records & retention times, plus multiple documents for easy implementation.
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Introduction to Quality by Design
Quality by design is how firms have been able to speed time to market, increase their pipeline success rate, and give their regulatory submissions a 66% edge above the competition. Based on Cerulean's full-day corporate workshop, this seminar lays out a core strategy for adopting quality by design - from preclinical through the postmarket.
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Preparing for FDA's Part 11 Enforcement and EU's Revised Annex 11
See how to minimize minimize risk, liability, and cost while meeting FDA's new expectations with 21 CFR Part 11 and the EU's revised Annex 11. Learn straight from a Part 11 expert who trained as an inspector. Get 12+ documents for quick and easy implementation.
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Quality System Management Reviews – A Lean Compliance Toolkit
Learn how to put in place a twelve-step annual quality system management review program that meets FDA, EMA, and Health Canada regulatory expectations. Seminar toolkit comes with multiple documents, checklists and reference materials for easy implementation.
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Supplier Selection, Qualification & Management – A Lean Compliance Toolkit
How firms oversee and manage their vendors is a critical concern for FDA investigators, patients and company shareholders. This recorded seminar provides a risk-based, cost-effective roadmap to supplier selection and management using a lean compliance strategy.
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There is no risk when you purchase Cerulean’s recorded seminars. See our online purchasing & return policy FAQ.
