2019 Regulatory Training

Training Sessions – can be delivered onsite or via web conference
contactus@compliancepath.com for price and scheduling

Data Integrity
• Same training delivered to US FDA Consumer Safety Officers
• Learn about Data Integrity Risks
• Learn about ALCOA principles
• Understand paper vs digital Data Integrity
• Examples of Regulatory Citations
• Assessing Data Integrity in EBR systems

Computer System Validation Training
• Same training delivered to US FDA Consumer Safety Officers
• Learn about general CSV principles
• Understand 21 CFR Part 11, EU Annex 11
• Risk based approach for ERP validation
• Risk based an approach for SCADA validation
• Risk based an approach for LIMS validation

Software as a medical Device (SaMD)
• A review of the applicable regulations and guidance documents
• Proper Application of IEC62304, ISO13485 and ISO14971
• Understand the process by which to classify Software as a Medical Device (SaMD)
• Classification of SaMD
• Software development and validation practices for SaMD

Cloud Compliance Benefits, Risks & Challenges in the GxP Domain
• Training delivered to US FDA Consumer Safety Officers
• Understand the challenges of GxP Cloud Compliance
• Learn about qualifying IaaS providers
• Learn about qualifying SaaS providers
• Learn about qualifying PaaS providers
• Understand US FDA expectations for Cloud delivered systems
• Understand risk profiles of different cloud types: Public, Private, Community, Hybrid