Course description
Writing Effective Nonconformity Statements During a Medical Device QMS Audit
This one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.
Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements. Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias.
In addition, learners will apply the knowledge gained during the course through the practical application of the concepts presented. 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.
Upcoming start dates
Suitability - Who should attend?
This course is vital for anyone who conducts or manages internal, supplier or third-party audits within the medical device manufacturing space. The tools and tips shared in this training will help ensure that the auditee organization clearly understands the nonconformities, so that they can identify and implement effective investigations and subsequent containment, correction, corrective action and systemic corrective actions, as appropriate.
Outcome / Qualification etc.
Key Learning Objectives
- Identify valuable 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
- Demonstrate through practical application the knowledge gained
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
General Registration $600.00