ASQ Certified Medical Device Auditor (CMDA) Refresher Course
3

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:

Class 1: Fundamentals of Auditing/Audit PlanningDate: Thursday, April 22, 2021

Types of Audits, Audit Roles and Responsibilities, Ethical, Legal, and Professional Issues

Instructor: Upen Patel; Time: 6PM to 9PM

Class 2: QSR/ U.S. Law Related to Medical Devices Date: Thursday, April 29, 2021

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: James Wabby; Time: 6PM to 9PM

Class 3: Audit Guidance: Performance, Reporting, Follow-up, and Closure:

Date: Thursday, May 06, 2021

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; Time: 6PM to 9PM

Class 4: European Regulation, Other International Regulation, Risk Management

Date: Thursday, May 13, 2021

EU MDR 2017/745, Health Canada, Other international agencies, Requirements for In Vitro Diagnostic (IVD) Devices, Post-Market Surveillance, Risk Management - ISO14971

Instructor: James Wabby; Time: 6PM to 9PM

Class 5: RoHs Directives, REACH, Laboratory Testing and Failure Analysis

Date: Thursday, May 20, 2021

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; Time: 6PM to 8PM

Class 6: Usability Engineering and Evolving StandardsDate:

Thursday, May 27, 2021

Human factors and usability engineering, General safety and performance Requirements, Sources for New and Evolving Standards

Instructor: Bob Mehta; Time: 6PM to 8PM

Class 7: International Standards, Validation

Date: Thursday, June 03, 2021

International Standards (ISO 9001, ISO 17025, ISO 13485)Validation IQ/OQ/PQ per GHTF/SG3/N99-10

Instructor: Upen Patel; Time: 6PM to 9PM

Class 8: Sterilization/ Controlled Environment/ Packaging/ Biocompatibility

Date: Thursday, June 10, 2021

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 ;Time: 6PM to 9PM

Class 9: Software Requirements in Medical Device, Other CFR (Labeling)

Date: Thursday, June 17, 2021

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 & Upen Patel; Time: 6PM to 9PM

Class 10: Quality Tools and Techniques, Process Improvements, Sampling

Date: Thursday, June 24, 2021

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

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Date & Time
Thursday April 22nd, 2021 8:00pm CDT
End Date & Time
Thursday June 24th, 2021 11:00pm CDT
Category Public Calendar

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Event Map

Date & Time: 04/22/2021 06:00:00 PM PDT