Qualification Training

Online training about the basis knowledge of the qualification (validation) of equipment, medias, clean rooms etc. in the pharmaceutical and medical device industry (Good Manufacturing Practice). After successful completion of the online training you will be Certified Qualification Specialist.

We train you in the qualification (validation) of equipment, medias, clean rooms etc. in the regulated environment (Good Manufacturing Practice)  and explain you the procedure of the qualification (validation) and prepare you the best on your new job.

Content:

• Training presentation (see agenda)
• Hand-out of the trainings presentation (PDF)
• Training documentation (PDF)
• Questionnaire for the final exam (PDF)
• Certificate after successful final exam (PDF via Email)

Agenda:

• Good Manufacturing Practice (GMP)
• V-Model
• User Requirement Specifications (URS)
• Qualification Plan (QP)
• Functional Risk Analysis (FRA)
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Deviations (DV)
• Qualification Report (QR)
• Handover Report (HR)
• Release for IQ, OQ, PQ
• High Level Risk Analysis (HLRA)
• Functional Specification (FS)
• Software Design Specification (SDS)
• Hardware Design Specification (HDS)
• Sensor Risk Analysis (SRA)
• Release for Production (RN)