CGMP Guidance for Phase 1 Clinical Supplies

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com

The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.

CGMP Guidance for Phase 1 Clinical Supplies

is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, June 15th, 2010. For more details or to register please visit our site at www.fxconferences.com

The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.

21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation

In 1991 the pharmaceutical industry met with FDA to determine how best to accommodate paperless record systems under CGMP regulations. The final result, published in 1997, was 21 Code of Federal Regulations Part 11. It provides industry with quantitative information for electronic records and signatures that can be used to add value to the validation of automated systems. Part 11 regulations can be used to accomplish three tasks: create new requirement specifications that comply with Part 11 regulations, assess existing automated systems for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated systems.

In this audio conference, attendees learn how they can quickly and easily assess and remediate their current systems for Part 11 compliance, and how to add value by incorporating Part 11 into the validation effort.

21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation is being presented by Jeffrey Gassman, President & Founder, of Validation Plus, Inc. and airs on Thursday, July 16, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com