Hvorfor vælge Key2Compliance® ?
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Kursusbeskrivelse
Course outline:
- USP Interpretations
- Laboratory Walk-through Inspection Coverage
- General GMP Requirements and Laboratory Controls
- Samples, reagents and reference standards
- Instrument calibration, maintenance, qualification and logbooks
- Investigations and change control
- Personnel qualification and training
- Stability program
- Raw material reduced testing program
- Retention sample program
- Microbiology Laboratory Controls
- Media control and media growth promotion, sterility testing, methods validation
- Laboratory Procedures and Documentation
- SOPs, raw data, electronic records
- Analytical Method Validation
- Laboratory OOS: Investigations and Retesting
Målgruppe
Who should attend:
This course is intended for the Quality Control, Quality Assurance and Compliance professionals who are directly involved with laboratory operations, or responsible for the compliance and auditing of laboratory systems and controls. The information in this course may be beneficial for Regulatory Affairs professionals who are responsible for FDA submissions.
Pris
Price (excl. local VAT):
Register by 26 Oct and save 1 500 DKK (€ 200)
Early bird: 13 780 DKK (€ 1 850)
Price: 15 280 DKK (€ 2 050) incl. course
Om udbyderen
Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse. Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...
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Key2Compliance®
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