QAtor standard training courses are designed by consultants well experienced in regulated environments helping Quality Assurance and Control staff to meet difficult compliance demands. Training sessions are dedicated to participants who work mainly in drugs manufacturing industry, in Quality Assurance or Quality Controlling Departments.
QAtor offers a standard package of trainings courses covering 3 levels:
- Training – basis
- Basic GMP
- Validation
- GMP testing
- 21 CFR Part 11
- Training - advanced
- Advanced GMP
- Passing an inspection
- Computer validation
- Retrospective validation
- Training - Specific GMP
- GAP analysis
- Auditor Course
Current openings for training courses include:
- Computer Systems Validation
- Test in GMP environment
- Creation of a validation plan
- 21 CFR part 11 compliance
- GAP analysis
Participating in our training courses will result in an overall reduction of the high risk exposure to regulatory non-compliance from the FDA regulatory agencies.
QAtor can also help develop internal education procedures on request according to client needs and demands. Standard or individually customized training offers include themes and features like:
- General issues, e.g. GAP analysis, within:
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- GMP (Good Manufacturing Practices)
- GLP (Good Laboratory Practice) &
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- Administration Configuration Training
- Compliance Flow Development Training
- Standard Documentation Forms Design
- Configuration Training
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For more details please contact
Computer Systems Validation Training Program
Computer system development and validation are one of the most challenging aspects of complying with FDA's 21 CFR Part 11. Since no two organizations are alike, we prepare a custom training program to ensure maximum knowledge transfer. QAtor will work with you to create custom training sessions to educate your users, and key stakeholders in regulatory compliance and system validation. Our Computer Validation training program covers the following topics:
- Introduction to computer validation
- Requirements from the authorities and guidelines
- Specification of requirements and planning of validation
- Verification of test
- Qualification
- Maintenance of validation
- Retrospective validation
- Risk analysis
For more details please contact
21 CFR Part 11 Compliance Training Program
The goal of the course is to give people involved in development, test and maintenance of systems that are to be compliant to FDA rules regarding electronic registrations, electronic signatures and audit trailing basic knowledge about the 21 CFR Part 11 rules. Furthermore the goal is to give some basic tools for part 11 analysis of any system.
21 CFR Part 11 Compliance training program cover the following topic:
- Introduction to definitions and requirements
- Introduction to the available guidelines
- Interpretation an suggestions to handling of Part 11 requirements
- GAP analysis
- Case Studies/ Examples
- Typical problems
- Customer problems and Warning letters
- Questions and Answers
For more details please contact
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