Would your organisation prefer to have specific training In-house?

RCWG offer a comprehensive range of In-house workshops which can be tailored to meet the specific needs of your organsisation. Choose from an extensive list of topics which can be offered as 1, 2 or 3-day workshops.

Pharma IT and related courses

• The Impact of the FDA’s NEW Guidance for Industry on 21 CFR Part 11, Electronic Records and Electronic Signatures
• Everything you Need to Know about 21 CFR Part 11: Basic Course
• 21 CFR Part 11, Electronic Records and Electronic Signatures: Advanced Course
• Understanding and Applying Risk Management to Meet FDA Expectations for Computerised Systems
• Auditing Computerised Systems to Pass FDA and European Regulatory Inspections
• Writing User Requirement Specifications
• Computer Validation: A 2-day Course
• Validation of Computerised Systems
• Network and IT Qualification
• LIMS: A 1-Day Short Course
• LIMS: A 2-day Intensive Course
• Regulatory Compliance for the IT Department
• Validation of Chromatography Data Systems
• The Real Business Benefits of Electronic Signatures
• Archiving and Maintaining Electronic Records to Meet FDA Expectations
• Dealing with the FDA Inspection Process

SOPs and Documentation

• Creating SOPs for Data Management to meet Regulatory Requirements
• Data Management Plans vs. Data Management SOPs binder
• Quality Control and SOPs
• Documentation and Validation

If the training you require is not included in the above lists, please contact RCWG and we will be more than happy to dicsuss your training requirements.