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webinar on Lifecycle Approach to Analytical Methods: Incorporating QbD Principles into Method Development, Validation and Transfer by global compliance trainings

 
  February 27, 2014  
     
 
Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
20-05-2014


Webinar Description :


This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically.
 
This approach will be linked with current compendial requirements.  There will be an opportunity for questions and answers at the end of the presentation.

Objectives of the Presentation: 

1)   Understand the lifecycle approach to method development and validation.

2)   Identify an Analytical Target Profile for Methods Being Developed

3)   Use an IQ/OQ/PQ Approach to Method Qualification

4)   Develop Appropriate Protocols for Method Transfer

5)   Comply with Compendial Requirements with Greater Success and Fewer Resources

 

Areas Covered:

·       Introduction:  Using a Lifecycle Approach for Analytical Procedures

·       Stage 1:  Method Design, Development and Understanding

o   Using an Analytical Target Profile to Guide Development

o   Using QbD Principles to Explore the Method Operable Design Space

·       Stage 2:  Method Qualification

o   Integrates Validation, Verification and Transfer

·       Stage 3:  Method Performance Verification

o   Developing a Control Strategy

                 Questions and Discussion

Who will benefit:  

Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

Why you should attend: 

The various stages of an analytical method, from development and validation through method changes, transfers to other labs and ultimately into the Compendia, are inextricably linked.  By applying pharmaceutical QbD principles to analytical methods, this Lifecycle Approach will help users to establish that link, using an Analytical Target Profile, which will assist in identifying the true expectations for the method performance and make progress through the various stages easier to accomplish. We will discuss how method uncertainty, risk assessment and exploring the Method Operable Design Region can lead to more robust methods.

Instructor Profile
Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. 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. He is also Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.
 

Live Session for one participant

Price: $225.00

 

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Corporate Live Session 4 to 10 participants in single location.

Price:$885.00

 

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Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.

Price: $275.00


 
 
 
Organized by: Global Compliance Trainings
Invited Speakers: Gregory P. Martin
 
Deadline for Abstracts: 20th May 2014
 
Registration: 20th May 2014
E-mail: webinar@globalcompliancetrainings.com
 
   
 
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