Annual Good Manufacturing Practices (GMP) updates are required by the FDA to assure facility personnel maintain a current understanding of regulatory requirements. These regulations utilize 21 CFR Parts 210/211 as the basis for understanding; however, many other documents to include FDA’s Guidance(s) for Industry, and various other policies, to include ICH Q8, Q9 and Q10, enhance the basis for these updates and regulatory expectations.

The objective of this comprehensive live & interactive Tungsten Shield 2-Part webinars is to explore 2013 GMP updates and FDA regulatory expectations and assist in assuring that your organization is maintaining itself within a cGMP compliance framework.

This Live Training Program will also use recent Warning Letters to illustrate some of the common repeated errors that companies encounter within the areas listed below and how incorrect responses may amplify their problems.

Please scroll down for complete details of both parts of this exclusive live training program.

Part 1 - 2013 Good Manufacturing Practices Updates; FDA’s New Initiatives, Audits and Changes to 21 CFR Parts 210 & 211

LIVE, INTERACTIVE WEBINAR
Thursday October 31, 2013
Time: 1:00pm - 3:00pm ET

Learning Benefits:
-Where the FDA is headed under its new Commissioner
-Learning how GMP Compliance can enhance the Efficiency of your Organization
-Determining if your Organization is meeting all Six Quality System Requirements
-How the revised 210/211 is allowing for Automated Equipment
-The "New" 2011 Process Validation -- An Overview of What It Includes
-What Happened to "Retrospective Validations" and What Happens Now
-How to use a Warning Letter to Improve the Quality within your Facilities
-An Opportunity to Learn how others are meeting cGMP needs during the “live” Question and Answer Session

Webinar outline and time breakdown:

Date: Thursday October 31, 2013 1pm ET

   Time*         Activity

*Please note all times are Eastern Standard Time

Part 2 - 2013 Good Manufacturing Practices Updates; Combination Products Codifications of Rules, Investigating OOS Test Results, USP <61>/<62> & ICH Q9

LIVE, INTERACTIVE WEBINAR
Date: Thursday November 14, 2013
Time: 1:00pm - 3:00pm ET

Learning Benefits:
-Codification of Combination Rules -- Why Everyone is Affected
-The Issues Surrounding Out of Specification Results and Why This Guidance for Industry Document continues to cause Industry Problems
-The Revisions to USP<61>/<62> Microbiological Examination of Non-sterile Products, and the Pitfalls Awaiting the Laboratory
-How ICH Q9, Quality Risk Management, Can Benefit your Organization
-How to use a Warning Letter to Improve the Quality within your facilities
-An Opportunity to Learn how others are meeting cGMP needs during the “live” Question and Answer Session

Webinar outline and time breakdown:

Date: Thursday November 14, 2013 1pm ET

   Time*         Activity

*Please note all times are Eastern Standard Time

List of handout materials included with this training program:

• A Copy of the presentation slides
• Reference to the ICH Guidances

Who should attend:

The following individuals or disciplines will benefit from attending this training program:

• Facilities
• Microbiology Professionals
• Quality Assurance personnel
• Quality Control personnel
• Research & Development
• Regualtory Affairs Professionals
• Validation
• Auditors

Click Here to Register for the 2 Part Live Training Program>>>