Quality System Regulations Training
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Module 1: Introduction to FDA and Quality System Regulations
$99.00An introduction to FDA and Quality System Regulations wherein participants will gain an understanding of the history of the Food and Drug Administration as well as an overview of Quality System Regulations. Learn More -
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Module 2: Management Responsibility
$99.00Gain an understanding of management’s responsibility to assess suitability, adequacy, and effectiveness of the quality management system through activities such as planning, resource management, audits, and training. Covers 21 CFR Part 820.2 (c) and reviews ISO 13485 Section 5.6. Learn More -
Module 3: Handling FDA Inspection
$99.00Prepare employees for hosting an FDA Inspection. Review the approach for handling FDA Inspections as well as ISO13485 Section 9.1. Learn More -
Module 4: Training and Document Control
$99.00Acquire knowledge about the development, approval, distribution, modification, and control of all product, process, and quality assurance documentation and gain an understanding of training requirements. Covers 21 CFR 820.25, 21 CFR 820.40, ISO 13485 Sections 4.2, 6.1, and 6.2. Learn More -
Module 5: Engineering Change Notices (ECNs) and Record Control
$99.00Gain an understanding of the requirements surrounding records retention and accessibility. Review the process of creating, editing, and approving controlled documents and the types of records that are required to be maintained and accessible. Covers 21 CFR Part 820.180, 820.181, 820.184, 820.186, 820.40 and ISO 13485 4.2.3 and 4.2.4. Learn More -
Module 6: Design Controls
$99.00Gain an understanding of the categorization of medical devices into class I, class II, and class III. Review the steps associated with designing medical devices, specifically: planning, gathering inputs and outputs, reviewing, verifying and validating, transferring, and changing devices. Learn how to document the design process in a design history file. Covers 21 CFR Part 820.30. Reviews ISO 13485 Section 7.3. Learn More -
Module 7: Risk Management
$99.00Review the approach for identifying hazards, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness . Gain an understanding of the techniques used to assess risk. Covers 21 CFR Part 820.30(g), ISO 14971:2007 – Risk Management and ISO 13485 Section 7.1. Learn More -
Module 8: Purchasing Controls and Receiving and Acceptance Status
$99.00Learn how to establish and maintain documented controls for planning and performing purchasing activities. Gain an understanding of the activities associated with receiving and assessing incoming, in-process, and finished product. Learn how to document acceptance status. Covers 21 CFR Parts 820.50, 820.80 & 820.86. Reviews ISO 13485 Section 7.4.3 and 7.5.3. Learn More -
Module 9: Identification and Traceability
$99.00Acquire knowledge about identifying and tracking product during all stages of receipt, production, and distribution. Learn More
