ASQ Certified Medical Device Auditor (CMDA) Refresher Course 3420
ASQ Certified Medical Device Auditor (CMDA) Refresher Course
2

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 Planning

Date: Saturday, October 2, 2021

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

Instructor: Upen Patel; Time: 8:30 - 11:30 AM

Class 2: QSR/ U.S. Law Related to Medical Devices

Date: Saturday, October 9, 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: 8:30 - 11:30 AM

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

Date: Saturday, October 16, 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: 8:30 - 11:30 AM

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

Date: Saturday, October 23, 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: 8:30 - 11:30 AM

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

Date: Saturday, October 30, 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: 8:30 - 10:30 AM

Class 6: Usability Engineering and Evolving Standards Date: Saturday, November 6, 2021

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

Instructor: Bob Mehta; Time: 8:30 - 10:30 AM

Class 7: International Standards, Validation

Date: Saturday, November 13, 2021

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

Instructor: Upen Patel; Time: Time: 8:30 - 11:30 AM

Class 8: Sterilization/ Controlled Environment/ Packaging/ Biocompatibility

Date: Saturday, November 20, 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: 8:30 - 11:30 AM

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

Date: Saturday, December 4, 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: 8:30 - 11:30 AM

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

Date: Saturday, December 11, 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

Instructors: Upen Patel; Time: 8:30 - 11:30 AM

Exam Window:

Six times per year (Refer to ASQ website). Lead Instructor:

Upen Patel: E-mail: Upen_Patel@Edwards

Date & Time
Saturday October 2nd, 2021 8:30am CDT
End Date & Time
Saturday October 2nd, 2021 11:30am CDT
Categories
Webinar, Certification Exam, Certification Deadline, Course
Host Type
Geographic, Technical
File
CMDA Flyer Oct-2021.docxCMDA Flyer Oct-2021.docx174 KB
Category Public Calendar

Event Comments

No Data Available

Event Map

Date & Time: 10/02/2021 08:30:00 AM CDT