Fee structure:
ASQ Member and Non-members - $399
ASQ Unemployed Members - $200**
**NOTE: To get access to Unemployed Ticket option please contact:
Lead Instructor:
Upen Patel
E-mail: Upen_Patel@Edwards.com
Event Summary:
Auditing Fundamentals, Auditing and Inspection Processes, US Laws: QSR: CFR Title 21, U.S. requirements (FD&C Act), QSR, EU MDR, Health Canada, Other international agencies, International Standards, Validation, Risk Management, Restriction of Hazardous Substances (RoHS), Human factors and usability engineering, Biological evaluation, Packaging, Device Shelf Life, Controlled Environments and Utility Systems, Sterilization, Software Development and Maintenance, Quality Tools and Techniques, Process capability, Six Sigma, Lean Tools, Cost of Quality (COQ), Sampling.
Event Agenda:
Total Sessions: 10When: Saturday, September 20, 2025, to November 22, 2025 Time: 8:30AM - 11:00AM (Pacific Time) Location: Live Webinar, California, USA Fee structure: $399 (member and non-members) and $200 for unemployed members
Class 1: Fundamentals of Auditing/Audit Planning
Date: Saturday, September 20, 2025, Time: 8:30AM to 11:00AM
Types of Audits, Audit Roles and Responsibilities, Ethical, Legal, and Professional Issues
Instructor: Upen Patel
Class 2: QSR/ U.S. Law Related to Medical Devices
Date: Saturday, Date: Saturday, September 27, 2025, Time: 8:30AM to 11:00AM, 2025
Regulatory Laws and Requirements, FDA - Code of Federal Regulations (CFR) Title 21,
Quality System Regulation (QSR) Requirements (21 CFR 820)
U.S. requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704),
Instructor: TBD
Class 3: Audit Guidance: Performance, Reporting, Follow-up, and Closure
Date: Saturday, October 04, 2025, Time: 8:30AM to 11:00AM
Audit Preparation and Planning, Audit Performance, Audit Report, Audit Follow-Up and Closure, FDA’s Quality System Inspection Technique (QSIT), FDA CPG 7382.845
Instructor: Upen Patel
Class 4: European Regulation, Other International Regulation, Risk Management
Date: Saturday, Saturday, October 11, 2025, Time: 8:30AM to 11:00AM 05, 2025
EU MDR 2017/745, Health Canada, Other international agencies, Requirements for In Vitro Diagnostic (IVD) Devices, Post-Market Surveillance, Risk Management - ISO14971
Instructor: TBD
Class 5: RoHs Directives, REACH, Laboratory Testing and Failure Analysis
Date: Saturday, Octobert 18, 2025, Time: 8:30AM to 11:00AM
Laboratory Testing and Failure Analysis, Safety and essential performance of medical electrical equipment (IEC 60601-1), Restriction of Hazardous Substances (RoHS) directive, Registration, Evaluation, Authorization, and
Restriction of Chemicals (REACH)
Instructor: Vinay Goyal
Class 6: Usability Engineering and Evolving Standards
Date: Saturday, October 25, 2025, Time: 8:30AM to 11:00AM
Human factors and usability engineering, General safety and performance
Requirements, Sources for New and Evolving Standards
Instructor: Bob Mehta
Class 7: International Standards, Validation
Date: Saturday, November 1, 2025, Time: 8:30AM to 11:00AM
International Standards (ISO 9001, ISO 17025, ISO 13485)
Validation IQ/OQ/PQ per GHTF/SG3/N99-10
Instructor: Upen Patel
Class 8: Sterilization/ Controlled Environment/ Packaging/ Biocompatibility
Date: Saturday, November 8, 2025, Time: 8:30AM to 11:00AM
Biological evaluation, Packaging, Device Shelf Life, Controlled Environments and Utility Systems, Sterile Medical Devices (Sterilization), Reprocessing/Reuse and Cleaning of Medical device, ISO 17665-1/2, ISO 11135-1/2, 11137-1/2, 11138-X, ISO 11737-1, 10993-1, EN 556-1, ISO 14644-1, 11607-1/-2, FDA Blue Book #G95, Federal Std 209E, US
Instructor: George Phillips
Class 9: Software Requirements in Medical Device, Other CFR (Labeling)
Date: Saturday, November 15, 2025, Time: 8:30AM to 11:00AM
Software Development (IEC 62366) and Software Maintenance , IEC 62304 (FDA Software Guidance),
Other CFR- Labeling (21 CFR 801, ISO 15223, 21 CFR 830)
Instructors: Karen Grams and Upen Patel
Time: 6PM to 9PM
Class 10: Quality Tools and Techniques, Process Improvements, Sampling
Date: Saturday, November 22, 2025, Time: 8:30AM to 11:00AM
Quality Control and Problem-Solving Tools, Process capability, Six Sigma, Lean Tools, Measurement system analysis (MSA), Cost of Quality (COQ), Qualitative and quantitative analysis, Attributes and variables data, Sampling
Instructors: Upen Patel
