Live webinar recorded on January 20, 2016.
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Warning Letters – 483 observations – CAPAs from a regulatory inspection! They happen to even the best of companies. And when they do happen you’ve got only 15 days to respond. A late or inadequate response could be disastrous to the company.
Wherever the remediation effort has been triggered, there are immediate steps you should take in order to help your firm navigate the remediation. This webinar will provide you with the steps necessary to reach a successful outcome.
This webinar is intended for medical device executives or those in industry who want to be prepared to deal with compliance issues or may be faced with a remediation project.
Attend this webinar to learn:
- Learn the strategic steps to a successful response while keeping your day-to-day business moving forward
- Manage executive expectations
- Understand the considerations for seeking outside support
Angela Brown is a Senior Consultant at Halloran Consulting Group. She has 20 years of regulatory affairs and quality assurance experience in the medical device industry. Angela is an expert in global regulatory strategy and submissions for new and existing product lines, developing quality systems processes, quality systems remediations, and working across multiple commercial and R&D functions.
Brian Scogland, MS, MBA is a Consultant II at Halloran Consultant Group. He has more than 10 years of experience in regulatory affairs and quality system development. Brian is an expert at creating and implementing quality systems in the medical device industry that ensure compliance with FDA’s quality system regulations, and conducts numerous mock inspections with sponsor companies to ensure regulatory compliance.