LIFE SCIENCES WITH PHONIZE
FDA Mock Audits and Quality System Gap Assessment and Performance Audits
FDA regulates the life sciences industry very actively through chal-lenging and sometimes overwhelming regulations. From medical devices and pharmaceuticals to biologics and biotech products, regulatory oversight is increasing with continued focus on areas like CAPA, risk management, vendor controls, and adverse event reporting during inspections. It is more important than ever for companies to continually understand what their regulatory risks are and to execute on plans to effectively remediate any gaps.
This course offers a full range of audits from basic gap assessments to comprehensive audits focused on root cause problem identification, performance evaluation, product/process monitoring, problem resolution and remediation.
BASIC, INTERMEDIATE & ADVANCED
- Complete QMS operations applying appropriate Good Manufacturing Practice regulations based on product(s) and processes covered
- Vendor and Purchasing Controls
- Adverse Event Reporting
- Document Control System
- Risk Management
- Promotion and Advertising
- Regulatory submissions review
- Business Owners
- Senior Managers/Managers and Leaders in:
- Quality Assurance
- Production and Operations
- Risk Management
- Regulatory Affairs
- Product Developmen
- Packaging and Labeling
“This is a quote about the course and how amazing it is. How much it helps my business!”
Why you should utilize external auditors :
An independent view of a company’s quality management system (QMS) can shed light on problems that are not seen during internal or corporate auditing activities. Well managed external audits that comprehensively evaluate the QMS against FDA’s quality system regulations and industry best practices, in conjunction will routine internal audits, is critical to helping reduce regulatory risk of an FDA enforcement action. Those audits also help improve the quality of products and processes, lower operating costs, and increase competitive advantage in the marketplace.
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Course Author Bio
An independent view of a company’s quality management system (QMS) can DA enforcement action. Those audits improve the quality of products and processes, loweroperating costs, and increase competitive advantage in the marketplace.