Sign In
Select Your Favourite
Category And Start Learning.
Certified Biomedical Auditor (CBA) Training
Course Content
• GETTING STARTED
-
How to Use the Alpha Training and Consulting Website
WELCOME TO YOUR CMDA (CBA) CLASS (WHEN I SAY “PRIMER” I MEAN “HANDBOOK”)
HOW TO SIGN UP FOR AN ASQ EXAM
AUDIO RECORDINGS (OPTIONAL) (AFTER LAUNCHING AUDIO YOU MAY HAVE TO LOGIN AGAIN)
TEST TAKING STRATEGIES MODULE 1(WHEN I SAY “PRIMER” I MEAN “HANDBOOK”)
TEST TAKING STRATEGIES MODULE 2 (WHEN I SAY “PRIMER” I MEAN “HANDBOOK”)
INTRODUCTION TO AUDITING
FORMING, STORMING, NORMING, AND PERFORMING
CONFLICT RESOLUTION
FUNDAMENTAL THEORIES
Introduction to Transformation
FIVE WHY’S (5 WHY’S)
QUALITY GURUS
Deming Story
INITIATING THE AUDIT
CONDUCTING DOCUMENT REVIEW
PREPARING FOR ON-SITE AUDITING ACTIVITIES
Conducting On-Site Auditing Activities
STANDARDS OF AUDITOR CONDUCT
COMPLETING THE AUDIT
CONDUCTING AUDIT FOLLOW UP
Preparing, Approving and Distributing the Audit Report
WORKING DOCUMENTS
AUDIT CASE STUDY 1
Audit Case Study 2
Fundamental Quality Tools
CONTROLLING PROCESSES
RISK MANAGEMENT
CENTRAL LIMIT THEOREM
MEASUREMENT SYSTEMS ANALYSIS (MSA)
VARIABLES DATA SPC (X BAR R)
Short Run SPC
MEDIAN CHART SPC
X BAR S CHART
P AND NP CHART
U AND C CHART
CAPABILITY STUDY
Z STATISTIC CAPABILITY
NON NORMAL DISTRIBUTIONS
ATTRIBUTE SAMPLING PLAN
VARIABLE SAMPLING PLAN
FDA HISTORY OF FDA REGULATIONS
FDA Misbranding and Adulteration
FDA INSPECTIONS
FDA Labeling Requirements
FDA Medical Device Reporting Requirements
• FDA SOFTWARE DEVELOPMENT
• FDA DEVICE TRACKING REQUIREMENTS
FDA MEDICAL DEVICE STERILIZATION
INTRODUCTION TO THE ISO ORGANIZATION
ISO 13485 QUALITY MANUAL (INTRODUCTION)
ISO 13485 QUALITY MANUAL (SECTION 4)
ISO 13485 QUALITY MANUAL (SECTION 5)
ISO 13485 QUALITY MANUAL (SECTION 6)
ISO 13485 QUALITY MANUAL (SECTION 7)
ISO 13485 QUALITY MANUAL (SECTION 8)
SYSTEMATIC PROBLEM SOLVING
QUALITY FUNCTION DEPLOYMENT (QFD)
About Course
The Certified Biomedical Auditor (CBA) certification, offered by organizations like the American Society for Quality (ASQ), is for professionals auditing quality management systems in the biomedical field. CBA validates expertise in biomedical regulations, quality standards, audit methodologies, and risk management specific to medical devices and pharmaceuticals. Holders of CBA demonstrate proficiency in ensuring compliance with regulatory requirements, evaluating quality systems, and implementing corrective actions to maintain product safety and efficacy. This certification enhances career opportunities by confirming skills in biomedical auditing, quality assurance, and contributing to the safe production and distribution of medical products to meet global healthcare standards.
