The current GXP regulations focus more and more on the topic of risk management in CSV. This seminar will provide you with guidance in carrying out risk assessments when validating computerized systems. The basis of the seminar will be the current requirements for the validation of computerized systems, such as GAMP®5, and their GxP-oriented application in practice.
Computerized systems are a central factor in achieving GXP compliance in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention, but this means that all computerized systems which can influence the quality of pharmaceutical products must be fully validated.
Lecture 1: Laws, Regulations and Guidelines for Computer Systems Validation & e-records
Lecture 2: Risk Management in Computer Systems Validation
Lecture 3: The GAMP®5 Approach to Computer Systems Validation
Lecture 4: The Computer Systems Validation Process
Lecture 5: Planning a Computer Systems Validation Programme
Lecture 6: User Requirement Specification (URS)
Lecture 7: Assessing & Selecting Suppliers
Lecture 8: Change Management
Lecture 9: Validation Reporting
Get fabulous discounts by participating in groups of two or more.
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
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