Dr. Shib Mookherjea is an internationally acclaimed speaker and consultant. He has extensive experience in R&D, Quality Assurance, and Quality Management. During the past 25 years, he has held both Senior Scientist and management positions within the R&D, QA, and regulatory areas with companies such as Johnson and Johnson, Colgate-Palmolive, BASF, and Troy Corporation/Troy Biosciences, CRO's and governmental organizations. He is a recognized expert in the fields of validation, QA, and QC in both the pharmaceutical and process industries.
The short courses personally developed by Dr. Mookherjea have been presented to thousands of attendees and target audiences over the last 20 years in several countries, across the related industries.
In addition to having served on many international scientific task forces, workgroups, and committees, Dr. Mookherjea is a lead auditor of ISO-9000 and has conducted many GLP and GMP audits. Dr. Mookherjea has a proven track record in training, complete project management, problem solving and extensive accomplishments in the areas of Pharmaceutical Development, Marketing, Quality Assurance, Quality Control, Process Upgrade, Analytical Support for Stability Studies, Environmental Studies, Worker Exposure (OSHA) and Validation in the Laboratory.
Register by mailing a copy of the REGISTRATION FORM. Send it with a payment of $1695 to secure your attendance. Hotel information and a map will be sent to confirm your registration. Please list your special interest(s) on the registration form. Enrollment is limited to assure your maximum course benefits. On-site PACS courses are available (most PACS courses can be provided at your time and place). Telephone Henry Nowicki or Barb Sherman at 1.724.457.6576 if you need further information. PACS also provides laboratory testing and consulting services.
The course is presented with the ultimate goal of providing understanding and comprehension of the basic concepts and applications relevant to the topic. Most of the topics embrace applications of scientific principles with highly complex technological applications and therefore, the level of comprehension is intense. To achieve effective knowledge sharing the attendees are encouraged to participate during the presentation. Therefore, the style of presentation is highly interactive and participative.
This course is designed with a fundamental grass roots approach to understanding measurement uncertainty and approaches validation in a very generic style.
The presentation aims at understanding basic elements of an analytical method both from the Quality Systems perspectives and with the more fundamental approach of measurement, errors and uncertainties in the analytical measurement process in particular.
A goal-oriented method development will be introduced with a generic, iterative and modular approach to understand validation in general at the same time establishing the capabilities of the analytical method as the method is being developed. The various stages of scoping out the method initially followed by an informed strategy of design, development and optimization to arrive at the validation parameters will be presented elaborately and lucidly.
Group exercise and case studies with real examples are integral parts of the presentation.
This very structured presentation continually builds on data handling, documentation and regulatory requirements for regulatory compliance issues. There is extensive guidance provided during the course for preparing validation protocols for various stages of IND, NDA and laboratory control, QA, QC inside companies. A brief discussion on statistical tools, SQC, SPC and stability indicating assays are included.
Course participants are encouraged to e-mail questions to Dr. Henry Nowicki at
Please NOTE: List your special interest on the registration form. We will try to accommodate your interest. PACS also provides internet consulting information at http://pacslabs.com
Training is an Investment in employee employer Future!
Henry Nowicki, Ph.D. / M.B.A
PACS Testing, Consulting and Training
409 Meade Drive, Coraopolis, PA 15108
Phone: 1. 724. 457. 6576 or 1. 800. 367. 2587
Fax: 1. 724. 457. 1214
E-Mail:
PACS website: http://pacslabs.com
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