This 510(K) training will help you understand and be prepared for substantial changes to the Premarket Notification 510(k) process for Class II medical devices.
In this webinar, essential pragmatic methods and practical tools will be discussed in detail - techniques and procedures that you will be able to implement immediately to guide your teams and ensure compliance with the upcoming changes related to Class II and Class III product registration requirements. The focus of this webinar is NOT on general theory of legal and regulatory compliance, but rather a practical ‘roll up your sleeves’ approach toward planning and implementing changes in your own company that will meet the upcoming FDA requirements for 510(k) cleared products.
Areas Covered in the Seminar: - An intensive, brief but in-depth review of FDA’s current policy relating to the 25 recommendations the Agency has states it intends to implement in 2011;
- Discussion of the FDA projected timeline for completing milestones for revamping the 510(k) review process;
- Specific discussion of the essential tactical activities and procedures that should be adopted by manufacturers this year to streamline compliance with the new regulatory requirements and FDA policy changes;
- We will review and discuss three free template documents prepared by the presenter, an FDA Regulatory Attorney, and provided to each Webinar participant:
- Corporate Policy for Compliance with FDA Changes to the Premarket Notification "FD&C Act sec. 510(k) Process", and
- SOP on How to Prepare a 510(k) Submission to Meet FDA Requirements – 2011
- Compliance Checklist - 510(k) Submission – 2011
- Discussion of the most common flaws and pitfall in product development programs that increase the regulatory burden on a manufacturer under the new FDA 510(k) process. These include:
- Enhanced 510(k) manufacturing data requirements,
- the type of safety and effectiveness information, including easy to implement "clinical literature review and compilation" practices,
- when to anticipate a pre-clearance inspection, and
- when to periodically report post-marketing information to FDA in lieu of submitting another 510(k)
- Practical and immediate steps to take to dramatically reduce the cost of regulatory compliance for Class II/III devices.
- Long-term strategies to ensure an efficient product development program
NOTE: Use This Promocode (
117660 ) To Get 10% Discount.
