Writing Effective Nonconformity Statements During Medical Device QMS Audits
Virtual Learning
Course Overview
This virtual instructor-led one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.
This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.
In addition, learners will apply the concepts covered during the course through practical application. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements.
This course pairs well with CQI IRCA-certified QMS Lead Auditor based on ISO 13485 2016 and MDSAP Requirements, EU MDR Internal Auditor (2 day), EU IVDR Internal Auditor (2 day), and MDSAP Internal Auditor Training (2 day).
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Identify useful techniques to apply when writing effective nonconformity statements
- Review fundamental terminology important to writing effective nonconformity statements including audit, objective evidence, audit criteria, and nonconformity
- Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement.
- Apply the three key principles when writing a nonconformity statement
Price: $800.00
Additional Recommended Courses
ISO 13485:2016 Fundamentals of Medical Devices QMS Requirements for Regulatory Purposes
This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.
This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Identify key documents to help you understand ISO 13485:2016
- Recognize the primary elements of ISO 13485:2016
- Identify terms and definitions relative to the application of ISO 13485:2016
- Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
- Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios
Price: $1200.00
ISO 14971:2019 Risk Management for Medical Devices and IVDs-Practical Application
ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.
This virtual instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process including review of TIR 24971:2020.
This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.
This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.
This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Identify regulatory requirements for risk management:
- European Regulation EU 2017/745 (EU MDR)
- European Regulation EU 2017/746 (EU IVDR)
- 21 CFR 820.30(g)
- Identify requirements of key International Standards relative to risk management:
- ISO 14971:2019
- ISO 13485:2016
- Recognize risk management definitions and principles
- Identify how risk management affects quality management system practices
- Recognize one method for the practical application of risk management principles
Who Should Attend
This course is vital for any medical device professional looking to expand their knowledge on comprehensive risk management processes and explain their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.
Price: $1200.00
CAPA Considerations: Problem Statement Writing and Investigation Techniques
Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners
with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms.
This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Define the purpose of Corrective and Preventive Action (CAPA)
- Identify and analyze data inputs for CAPA
- Compose a proper and complete problem statement
- Apply investigation techniques to identify root causes and define the appropriate corrective action
- Identify effectiveness criteria and perform an effectiveness check
- Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.
Price: $1200.00