Webinar ID:   ICT121

Medical Device QMS and Software Validation Workshop

ON-DEMAND
  7 Hours (2 Days)

Categories:   Medical Devices,
WORKSHOP AGENDA & DATES

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

ICT121

ComplianceTrainings Experts

This product may have multiple presenters.

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Software Developers
  • Software Engineers
  • IT Personnel
  • Device Development Managers
  • Systems engineers responsible for developing requirements
  • Test Engineers
  • Quality System auditors
  • Engineering managers and personnel
  • Everyone tasked with product, process, software validation responsibilities

Please contact our support team for assistance. Kindly send an email to info@compliancetrainings.in