Personal Information
Organização/Local de trabalho
San Francisco Bay Area United States
Setor
Medical / Health Care / Pharmaceuticals
Sobre
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...
Marcadores
compliance
regulatory
fda
quality
impact assessment
risk management
tools
medical drvice
pharmaceutical
change control
capa
Ver mais
Apresentações
(1)Documentos
(1)Personal Information
Organização/Local de trabalho
San Francisco Bay Area United States
Setor
Medical / Health Care / Pharmaceuticals
Sobre
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...
Marcadores
compliance
regulatory
fda
quality
impact assessment
risk management
tools
medical drvice
pharmaceutical
change control
capa
Ver mais