Mobirise

Compliance Support

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Conducting and preparing for Internal and External Audits
Instituting policies on dealing with Regulatory Agencies
Preparing or reviewing Mater Compliance Plans
Field Alert Filings and Management
Product Recall Strategy and Management
Requesting and Representation at FDA meetings
Follow up with District Offices and/or Office of Compliance
Preparing and implementing Vendor Qualification
Preparing and implementing Reduced Testing Program
Responses and remedial plans for Form 483’s, and Warning Letter’s
Preparing Standard Operating Procedures in line with regulations and current guidance's in effect
Preparing Documents routinely requested during regulatory inspections
Preparing and executing quality agreements, quality questionnaires etc.
Strategies to kick in compliance inspections to expedite application approval