Good day Anon,
There are many different answers to your query, and many different ways to do this, so I am not sure there would be sufficient time/space to put something here in a forum post. I can give you a brief thought on my own experience working at a small company keeping up with regulatory intelligence. I usually devoted an hour or two, one day a week to review websites, industry forums, standard publications, newsfeed, newsletters, etc., which you can find information such as through RAPS or other sources like MedTech Insight. Even signing up for email listing through US FDA is helpful because they send out emails on new guidance, regulations, and webinars on different topics. Then integrating all of this into the quality system, typically just used a simple Excel spreadsheet to put the date, item of review, impact review, and then actions which need to be taken. There are more complex and sophisticated ways of doing this, even up to getting subscriptions from companies which provide this information. It is indeed challenging and I still devote some time each day for reviewing regulatory intelligence.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-May-2023 22:55
From: Anonymous Member
Subject: Tools, strategies and best practices for regulatory task management
This message was posted by a user wishing to remain anonymous
At our small manufacturing company, we are faced with the challenge of having limited budget, personnel and skills allocated to regulatory efforts. Nonetheless, we are eager to enhance our proactively approach in reviewing internal regulatory assessments, identifying upcoming regulatory changes and ensuring compliance with applicable international regulations.
I would greatly appreciate it if you could share your strategies and best practices in effectively managing overdue/impending tasks and navigating complexities of internal and external regulatory requirements?
What process, tools or methodologies have you found helpful in identifying and prioritizing tasks, considering limited resources?