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  Medical Device Manufacturing

Medical Device Process Validation

The FDA’s Quality System Regulation (QSR) requires process validation. Using the FDA guidance documents, learn the concepts of process validation and the role of statistical methods such as SPC or DOE. The seminar also covers ISO 13485 requirements, and shows how to take OSHA regulations into account. In addition, the seminar shows the relationships among process validation, risk analysis, and CAPA. This seminar provides a comprehensive view using process and product examples to illustrate the concepts, and includes example procedures, work instructions, and training requirements. You will also get the Ombu Process Validation Toolkit, a collection of Excel spreadsheets to help understand and implement many of the seminar concepts.

Risk Analysis

Risk analysis is a required part of every medical device manufacturer’s quality system. This seminar presents the concepts of risk management, using ISO 14971:2007, and applies them throughout the product life cycle starting with design and creating a closed loop through market surveillance. The seminar shows the relationships among risk analysis, customer complaints, CAPA, and medical device reporting. The participant material includes example procedures, work instructions, and training requirements. You will also get the Ombu Risk Analysis Toolkit, a collection of Excel spreadsheets to help understand and implement many of the seminar concepts.

CAPA System

An effective corrective and preventive action (CAPA) system has a solid return on investment. In addition, an effective system is a regulatory requirement, and one of the most common quality system failures cited by the FDA. This seminar explains the requirements and helps you plan and implement an effective system that complies with both FDA’s QSR and ISO 13485. The seminar explains the relationships among correction, corrective action, and preventive action. The seminar shows how to tie the CAPA system to customer complaints, management reviews, risk management, and medical device reporting. The seminar uses examples to illustrate the concepts. The participant material includes example procedures, work instructions, and training requirements. You will also get the Ombu CAPA Toolkit, a collection of Excel spreadsheets to help understand and implement many of the seminar concepts.

 
 
 
 
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