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Seminars & Resource Kits for Compliance Success

Timely and trusted FDA quality systems advice and compliance intelligence

 

Recorded Seminars & Resource Kits

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Lean FDA Compliance
	FDA Quality Systems Records Requirements - GLPs, GCPs, GMPs Bulletproof Yourself against FDA Enforcement Best Practices for Your Quality System Management Review (QSMR) Effective Compliance and Quality Systems Oversight for Executives: SOPs & Policies Managing Supplier Risk - FDA Expectations Lean Outsourcing and Supplier Selection FDA GMP Enforcement Trends and Priority Target Areas in Quality Systems Frugal FDA Compliance and Quality Systems
IT Compliance (Part 11, Annex 11, etc.)
	Understanding and Implementing the Revised FDA Part 11 and EU Annex 11 Role of IT in Regulatory Compliance Validation, Data Integrity and Easing Your Pain when Dealing with IT and Part 11 Best Practices for IT Change Control
FDA Quality by Design
	Introduction to Speeding Drug Development With Quality by Design How to Improve Data Quality and Record Integrity in Your NDA, 510(k), or BLA
Corporate Espionage / Trade Secret Theft Prevention
	Preventing Intellectual Property Theft by Partners and Contractors

 

CDs are usually available one to days after the live webinar and include the speaker's slides, the recorded audio-visual presentation, all reference materials, toolkit items, handouts, the Q&A session with attendees, plus a customizable training certificate.  All purchasers also receive a complimentary six-month trial to Cerulean's SmarterCompliance newsletter of FDA intelligence, regulatory analysis, and expert quality systems recommendations.

To learn more or order a recorded seminar with online purchasing, click each title.  To order multiple titles and CDs, or to pay via invoice and check, download and use our quick order form.

Attendance at most live webinars is $325.  Most recorded versions on CD with reference materials, etc. are $325; we can also set up an on-demand download typically within 48 hours of request.*

 

*Note:  Paid newsletter subscribers save 20% on all live seminars; "Gold" SmarterCompliance™ Advisory Program members receive one free recorded seminar per year plus 30% discounts on all recorded and live seminars; "Platinum" members have free access to all recorded seminars and live webinars.  Please login now.

 

 

Satisfaction Guaranteed

There's no risk when you purchase from Cerulean Associates LLC with our money-back guarantee.  Not satisfied with your recorded CD?  Return it within 30 days of purchase (in resalable condition) along with the specific reasons for your return, and we will refund 100 percent of your purchase price (less shipping & handling and bank transaction fee).  For the downloadable format, you must notify Cerulean Associates LLC within 24 hours of purchase to receive a refund (less bank transaction fee).  For more information or other frequently asked questions about online purchasing, see our online purchasing and return policy FAQ.

 

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