This Event has Passed
Tuesday, September 16, 2014
10:00 AM - 11:00 AM
10:00 AM - 11:00 AM See all dates and Times
http://complianzworld.com/Webinars.aspx?TopicId=485&Sub=Effective-Investigation-of-Out-of-Specification,-Out-of-Trend-or-Atypical-R
Description: This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Course Objective:
• Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations.
• Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
Course Outline:
Basis for Qualification
• Calibration and qualification of equipment requirements in GMP guidelines for FDA and EMA
• USP General Chapter Analytical Instrument Qualification
• USP General Chapter Dissolution refers to Performance Verification Test
Approaches to Dissolution Instrument Qualification
• More challenging due to chemical, physical and temporal factors affecting results
• Mechanical specifications available for vessels, stirring units and assembled instrument
• USP Reference Tablets allow holistic evaluation of apparatus
Attendee questions
Target Audience:
Chemists, Supervisors and Managers in Pharmaceutical Laboratories and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment.
Speaker Profile : Gregory Martin
Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.
Event Price Tags :
$ 229.00 Single Attendee
$ 749.00 Group – Max 10 Attendees per location
$ 279.00 Access Recorded Version online
$ 349.00 Buy Training CD-DVD
For More Details or Enrollment Or Registration :
Contact : complianzworld
Phone : +1-866-978-0800
Fax : +1-888-883-7697
Course Objective:
• Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations.
• Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
Course Outline:
Basis for Qualification
• Calibration and qualification of equipment requirements in GMP guidelines for FDA and EMA
• USP General Chapter Analytical Instrument Qualification
• USP General Chapter Dissolution refers to Performance Verification Test
Approaches to Dissolution Instrument Qualification
• More challenging due to chemical, physical and temporal factors affecting results
• Mechanical specifications available for vessels, stirring units and assembled instrument
• USP Reference Tablets allow holistic evaluation of apparatus
Attendee questions
Target Audience:
Chemists, Supervisors and Managers in Pharmaceutical Laboratories and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment.
Speaker Profile : Gregory Martin
Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.
Event Price Tags :
$ 229.00 Single Attendee
$ 749.00 Group – Max 10 Attendees per location
$ 279.00 Access Recorded Version online
$ 349.00 Buy Training CD-DVD
For More Details or Enrollment Or Registration :
Contact : complianzworld
Phone : +1-866-978-0800
Fax : +1-888-883-7697
