A world renowned and accomplished Pharmaceutical,Biotechnology and Medical device GXP Consultant with a record of getting things done in the following areas:
1.New Product Design and release
2.Process validation
3. Change control: use of Quality Risk Management and Risk assessment
4.Process control: Process validation,SPC and Robust process design through QbD.
5.Consent decree ,warning letter,and 483 resolution
5.Process design:use of QTP, QbT, CQAs and Design Space
6.GxP Training:Process validation, Change control,CAPA and supplier Quality Management
7.Quality system audits
8.Supplier evaluation and Qualification
9. cGMP training
10.Sterilization.
11. USP water system installation and i...
