Past Events (3,027)

ICH Q10; moving from GMPs to a Pharmaceutical Quality System - Webinar By ComplianceOnline

July 24, 2012 from 10am to 11:30am – Online Event This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality… Organized by Referral | Type: pharmaceutical, training

Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

July 19, 2012 from 10am to 11am – Online Event This webinar will address the most current (regulatory) expectations for cleaning validation of reusable medical devices that are performed in support of the instructions in the instruction for use (… Organized by Referral | Type: medical, training
2-day In-person Seminar: Understanding and Implementing the Medical Device Directive

July 19, 2012 at 9am to July 20, 2012 at 5pm – Courtyard Philadelphia Downtown Course Description: Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be… Organized by Referral | Type: medical, training

An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products

July 18, 2012 from 10am to 11am – Online Event This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various opt… Organized by Referral | Type: pharmaceutical, training

Gaining and Re-Establishing Control of Your Cleanroom

July 12, 2012 from 10am to 11:30am – Online Event This 90-minute webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion… Organized by Referral | Type: pharmaceutical, training
Supplier Management for FDA Compliance - Webinar By ComplianceOnline

July 12, 2012 from 10am to 11am – Online Event This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving complianc… Organized by Referral | Type: medical, training

3-hr Virtual Seminar: IND Applications for Phase I Studies

June 29, 2012 from 10am to 1pm – Online Event This 3-hr virtual seminar will review FDA’s IND requirements for Phase I and First-in-Man (FIM) clinical trials. It will cover the structure of an IND document and discuss granular and sectional IND… Organized by Referral | Type: pharmaceutical, training
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

June 29, 2012 from 10am to 11:30am – Online Event This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certific… Organized by Referral | Type: medical, training

FDA’s Regulation of Veterinary Regenerative Medicine - Webinar By ComplianceOnline

June 28, 2012 from 10am to 11am – Online Event This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a… Organized by Referral | Type: pharmaceutical, training
One and Half-day In-person Seminar: Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop

June 28, 2012 at 8am to June 29, 2012 at 5pm – Grand Hyatt San Francisco Course Description: Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary investment burn.Mark DuVal, a national authority on the 510(k) program i… Organized by Referral | Type: medical, training