Session 1:
IEC 62304 AND EFFECTIVE SOFTWARE VALIDATION
Speaker: LAKSHMAN PRAKASH B
28 September 2020 | 6.30 – 8.15 PM
- Understanding IEC 62304
- Design Control
- Configuration management
- Software validation more than testing
- Requirements traceability
- Risk analysis
- Unit, integration and system testing
- Algorithm validation
- Challenges to the software
Session 2:
SECRETS TO WRITING EFFECTIVE SOPS FOR MDQMS
Speaker: SUSANNE MANZ
28 September 2020 | 8.15 – 9.30 PM
- Regulations & FDA Expectations
- Lessons Learned and Common Mistakes
- Preparing for an Inspection
- FDA expectations for SOPs
- Lessons Learned from 483s and warning letters; Common problems & mistakes
- How to structure your QMS and SOPs
- How to outline and format your SOPs
- Should, Shall, May, Do Not, Guidance
- Complete and concise
- Using process maps to make procedures clear
- Using diagrams and visuals
- Maintaining and controlling SOPs
- Ensuring adequate training to your SOPs
- Best Practices
Session 3:
MEDICAL DEVICE CYBERSECURITY FOLLOWING LATEST FDA GUIDANCE
Speaker: CAROLYN TROIANO
29 September 2020 | 6.30 – 8.15 PM
- Cybersecurity and guidance on device software
- Cybersecurity Plan
- Most common problems faced by the industry in terms of medical device security, efficacy, and safety
- Risk-based Analysis
- Hazard Analysis following ISO14971
- Risk Communication to users
- Required Membership in information sharing groups
- Reporting Requirements and Exceptions
Session 4:
VERIFICATION vs VALIDATION – PRODUCT, PROCESS OR EQUIPMENT AND QMS SOFTWARE
Speaker: JOHN E. LINCOLN
29 September 2020 | 8.15 – 9.30 PM
- Verification or Validation – Recent regulatory expectations
- The Master Validation Plan / structure
- Process / Equipment / Facility Validation – FDA’s new guidance
- When and How to use DQ, IQ, OQ, PQ, or their equivalents
- How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
- The 11 key documents for software validation
- Incorporating 21 CFR Part 11 requirements
- Suggested “test case” formats
- Production / test equipment / software examples
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