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.
Showing posts with label Marion Weinreb and Associates. Show all posts
Showing posts with label Marion Weinreb and Associates. Show all posts
Monday, August 23, 2010
Wednesday, July 14, 2010
QA Oversight of Contractors
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc and airs on Tuesday, August 24th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com
Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Wednesday, May 12, 2010
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.
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.
Thursday, February 11, 2010
QA Oversight of Vendor Management
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Wednesday, March 17, 2010. For more details or to register, please visit our site at www.fxconferences.com
Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
Monday, August 24, 2009
QA Oversight of Vendor Management
Managing vendors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.
This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
QA Oversight of Vendor Management is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 13, 2009. For more details or to register, please visit our site at www.fxconferences.com
This conference discusses what a quality agreement is and how to use it as a tool in managing your vendors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.
QA Oversight of Vendor Management is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, October 13, 2009. For more details or to register, please visit our site at www.fxconferences.com
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