I use a variety of regulations and recommendations from state authorities or professional organizations (EudraLex, EMA, FDA, WHO, ISO, PDA, PIC/S, Ph.Eur., USP and International Society for Pharmaceutical Engineering – ISPE)
Special consultancy
My team will provide you qualified consultancy in these areas:
- Quality assurance system and quality system audits
- Preparation of documentation system, support in implementation of quality system and documentation
- Legislative requirements in pharmaceutical production
Risk assessment
I can assess risks
- for requested process
- for production equipment or a set of production equipment
- for rooms
- for systems
Together with you I will set up CAPA (Correction Action and Preventive Action).
IT & GAMP
I will advise you on information systems in these levels
- formation of information strategies
- preparation of User requirements specifications (URS)
- preparation of SOP and operating instructions
- system life cycle determination