Cgmps Web-based Seminars

GMP Compliance for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: The U. S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. Wednesday, June 13, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs. Wednesday, June 20, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Zero Defects and the CGMPs - Pros and Cons - Webinar By GlobalCompliancePanel Overview: U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). Wednesday, April 11, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Leadership - In the Non-Leadership Position - Webinar By GlobalCompliancePanel This webinar will provide valuable guidance to personnel in regulated companies who are in roles viewed as merely support to those in formal leadership positions. Wednesday, December 7, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Recent Major Industry CGMP Failures and How to Avoid Them U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/ 211, and 820). They are then required to translate those regulations into procedures and work instructions.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/ DD is moving in the direction of the DHF. And the DHF is adapting to some of  more...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel ...ion and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel ...ations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis on proving a company is "in control" to an investigator's satisfaction, which has to center on  more...