The workshop is dedicated to senior analysts and laboratory Management of (bio)pharmaceutical and food laboratories. The workshop will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. Practical examples and interactive exercises will be dispersed into and between the presentations. About 50% of the total will be dedicated to practical sessions with life examples.








Contents overview:

• FDA/EU, ICH, USP and ISO 17025 requirements, regulatory expectations and inspection practices
• Understanding what questions will be asked during audits and inspections 
• Developing a validation plan and protocol in line with regulatory and quality standard requirements 
• How to form a validation and team and understand key expectations of each member. 
• Define the scope of methods, validation parameters and acceptance criteria 
• Prerequisits for method validation: SOP‘s, qualified instruments and qualified of materials 
• Design experiments for 9 validation parameters 
• Defining the minimum number of validation experiments that satisfy ICH, FDA, ISO 17025 and USP 
• Statistical evaluation of validation results for: repeatability, intermediate precision, linearity, reproducibility, limit of detection, limit of quantitation, robustness, specificity and range 
• How to transfer analytical methods according to USP <1224> 
• Verification of standard and compendial methods according to USP <1226> 
• Recommendations what, when and how to revalidate after changes according to United States and European Pharmacopeia 
• Criteria for method adjustments vs. Changes and the impact on revalidation and documentation 
• Development and validation of stability indicating methods using stress testing 
• Preparing validation reports in line with regulations and quality standards
  

Target Audience

• Laboratory management, supervisors and senior analysts
• QA managers and personnel
• Regulatory affairs
• Consultants

From

• Pharmaceutical and API manufacturers
• Clinical research organizations
• Contract laboratories
• Regulatory agencies

Date & Location

The Workshop will take place during analytica Anacon India, on 13th October 2011 (10am - 6pm), at BEC (International Lounge)

Attendance Fee
Per person Rs. 2.500,- to be paid in advance or onsite.

DOWNLOAD Workshop Registration Form


About the speaker
Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the on-line resource for validation and laboratory compliance. He studied chemistry and received his PhD. From the University of Karlsruhe, Germany. He is also the author of the books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories”. Currently Dr. Huber is on the Scientific Advisory Board of IVT’s GxP and Validation Journals, and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This includes seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies.