WORKSHOP
Fundamentals and Essentials of Validation in Pharmaceutical Industry
September 12, 2004
Course Overview
Validation has become the most complex, costly and time-consuming aspect of all activities that a healthcare manufacturing company needs to perform in order to comply with Good Manufacturing Practices (GMP). Why do we do it, what are the benefits?
Regulatory authorities, in their effort to protect the health and safety of patients, insist that validation be performed in all areas of product development, production, and quality control testing. This course covers all the elements of the five validations required by manufacturers to satisfy the regulatory authorities (including the United States FDA).
The course presents the four qualification phases of validation and the five different validation efforts in a logical and organized manner. The course describes exactly what is required, how to plan for validation and who in the company should carry out which aspects of the validation exercise. Drawing on worldwide experience in validation activities, the course presents examples of companies doing validation right and companies doing validation wrong! Validation, efficiently performed, provides significant benefits and cost savings to companies, in addition to allowing speedy product and facility approval during government inspections.
Course Programme
Benefits of attending
At the end of the course you will...
understand how validation can save the pharma company money and help rapidly bring drug products to market.
know the pitfalls of validation and how to avoid them.
be knowledgeable in all aspects of the validation process.
appreciate the complexity of validation and the contribution various disciplines can bring to ensuring validation is completed efficiently and cost-effectively.
Course Outline
Overview and background
What is validation, why is it required, what are the regulations, international regulatory requirements (United States FDA, European Union, Japan, ISO-9000), industry trends, the cost of validation.
Concepts and terms
Definitions and requirements of: metrology (calibration), protocols, design qualification, installation qualification, operational qualification, performance qualification, validation, recovery testing, validation master plan, retrospective validation, concurrent validation, prospective validation, acceptance criteria, validation summaries and reports, life cycles in pharmaceutical industry.
Process validation
Requirements and Techniques involved with Validation of:
– Active Pharmaceutical Ingredients (APIs)
– Pharmaceuticals (sterile and non-sterile)
– Biotechnology products
Analytical method validation
The seven essential elements of analytical method validation: accuracy, precision, selectivity, specificity, linearity, limits of detection, limits of quantitation and ruggedness. The role of research and development in validation. Technology transfer documents and development reports. Laboratory equipment qualification.
KUBABA Tourism & Travel Agency
Güniz Sokak No:44/1 Kavaklydere/ANKARA
06700 Ankara TURKEY
Phone: +90 312 428 0400
Fax: +90 312 428 0305
e-mail: nermine@kubaba.net
Workshop Secreteriat:
Hacettepe University Faculty of Pharmacy
Dept. Pharmaceutical Technology
06100 Syhhiye/ANKARA-TURKEY
Phone: + 90 312 305 1241
Fax: + 90 312 310 0906
e-mail: huetb-e@tr.net
