Keeping RA/QA Staffs Current

Tuesday, February 12, 2013

China has announced major revisions to their regulation of IVD’s - will your organization comment? 

Reforms to the EU IVD Directive will reclassify many devices to require review and approval - is your team ready?

Does your team interpret current FDA guidance consistently? Take advantage of key learnings across the industry?

It’s an ever changing landscape of regulation and guidance. We learn more with each agency publication and each new interaction, but are we sharing it with the team? Does each RAQS staffer have to find, read, and interpret the information for themselves?  

There’s not a system to capture and disseminate everything, but using a few diverse tools can improve the speed of communication and regulatory understanding.  Here are a few tried and true tips to help keep the information channels open and improve efficiency of information exchange for your team.

Divide and Conquer – No one can be an expert in every area.  Establish a few key resources on your team to track, and broadly communicate key policy changes.  Examples might be:  Post market surveillance, IDE Pre-Sub and IDE, EU regulation or perhaps regional specialist for Asia Pacific or Latin America. 

These resources can also collate input to proposed regulation and propose comment that represents your business interests, attend industry meetings and disseminate new information.

Establish a Communication Forum – A central clearing house for determining which emerging regulatory changes will require organizational or cross functional action.  The forum can identify, prioritize and track progress for actions.  If China regulations require new documentation formats for example, the Forum can propose a team to address and get management buy in to support the needed work in order to be prepared when regulations go into effect.

Document, Document, Document - All those agency contacts, little tidbits of information you wish someone had told you before you got the question from FDA.  Maybe you vaguely remember hearing something about FDA acceptance criteria for your product type, but you can’t recall who you heard it from…..keep a record of all agency contact information in a standard format.  Title these by product or project type and file them on a shared drive for easy retrieval.  Make sure you record the details of your information: source, timing, and context, to make sure the information is easily and accurately evaluated by future readers.

Knowledge is Power – But only if you share it.  Establish a culture of openness and sharing across your organization. If each individual could have, at their fingertips, the cumulative knowledge of your organization, imagine the quality of work and speed of response for your stakeholders. 

Reward knowledge sharing and mentoring.  Tell all of your stakeholders about major changes in regulatory and quality.  They’ll respond best if they know what’s coming.

We have all struggled with the rapid changes, unclear guidance or inconsistency of regulation, and difficulty of organizational communications.  These are just a few approaches that have worked well for me.  What other tools have you found helpful?  I’d love to hear your success stories.  What worked for you?

Tags: Best Practices, regulatory affairs

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