Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologie

Venue: Online Training Webinar

Location: Wilmington, Delaware, United States

Event Date/Time: Mar 29, 2011 End Date/Time: Mar 29, 2011
Report as Spam

Description

Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method.

This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities.

Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities.

Areas Covered in the Session:

* Review current regulatory status of rapid method acceptance
* Regulatory publications and presentations focusing on RMM implementation
* Current perspectives from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA)
* Use of comparability protocols
* Submission strategies
* Concept of research exemptions

Who Will Benefit:

* Microbiology
* Quality Control
* Quality Assurance
* Manufacturing
* Validation
* Regulatory Affairs
* R&D
* Discovery
* Finance

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Venue

1000 N West Street | Suite 1200
Wilmington
Delaware
United States
MORE INFO ON THIS VENUE