Areas Covered in the Webinar:
Verification & validation types.
Consequences of poor verification & validation.
Why verification & validation makes good business sense?
To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
To provide attendees with the Dos and Don'ts for an effective and efficient risk management system.
Do you worry about an upcoming FDA inspection?
Do you know how you should behave during the inspection?
Do you know what an end to end FDA inspection process looks like?
Do you know what an FDA investigator(s) will look for?
Do you know how to proactively assess and mitigate FDA compliance risks?
Do you know what information you should get ready ahead of an FDA inspection?
Does your organization have a game plan for managing an FDA inspection?
Does your organization know how to respond to and manage FDA observations (483s), or warning letters?
Learn about the regulatory background and requirements for laboratory instrument qualification and system validation
Understand the logic and principles of instrument qualification and system validation from validation planning to reporting
Understand and be able to explain your company’s qualification and validation strategies
Be able to independently prepare execute test protocols, this includes setting specifications and acceptance criteria
Understand how to review and approve qualification and validation protocols
Be able to develop inspection ready qualification and validation deliverables
Learn how to avoid and/or respond to FDA inspectional observations and warning letters.
Upon completing this course participants will understand:
Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
When to file for a new device, a change in the intended use or a change in the technology of a cleared device
What is contained in a traditional, abbreviated and special 510(k) submission package
The submission package, user fees and making an eCopy
What is substantial equivalence and what’s required to show substantial equivalence
What’s required on the labeling and IFU
Which performance tests should be conducted and how to present the data to the FDA
The requirements for a risk management plan and report
Understand the FDA’s Refuse to Accept Policy
What is required in a submission for software controlled devices
How and when to use third party reviews
When clinical data may be required.
Understand the importance of food and nutritional supplement GMPs in protecting the public
See the impact of poor GMP performance
Become a HACCP subject matter expert
Understand the impact on product quality and on business success
Know how facility design affects product quality
Understand the dos and don’ts of product promotion, websites and social media
Learn about GMP validation – when is it required?
Understand how cleaning agents work and the best way to choose a cleaning agent
See the impact of proper documentation and record keeping
Understand why cleanliness is the key to success.
See how Wallace Company, a Malcolm Baldrige Award Winner, changed from a rigid hierarchical organization into a model of teamwork and personal empowerment through a commitment to quality. Hosted by In Search of Excellence co-author
ISO 9000:2000 INTERNAL AUDITOR Training,1-3 days,What
are changes to theISO 9000:2000?,What to Look For As
an Auditor,Auditing Techniques,Developing a
Checklist,Questioning Techniques&Perform an actual
High energy, interactive 3-day PMBOK-based course for
Proj.Mgrs. Teaches processes/ techniques for shaping,
energizing, motivating project teams to get
faster/better results with Collaboration,“The Tenth
Knowledge Area.Bob Moir 404.338.0715