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Audit / Inspection Readiness and Response Services
Prepare with precision. Execute with poise. Respond with confidence.
Mastering compliance through strategic readiness programs and expert response and remediation.
J Michener Whipple & Partners LLC provides specialized expertise in preparing manufacturers for high-stakes regulatory scrutiny. We provide thorough readiness programs, and can manage back-rooms to ensure seamless execution during audits and inspections. When challenges arise, we provide expert guidance on FDA 483 responses, Notified Body responses, Warning Letter response and remediation, as well as health authority interactions, leveraging over 35 years of domain knowledge to safeguard your compliance standing.
- Expertise in FDA 21 CFR Part 820 Quality Management System Regulation and Part 4 Regulation of Combination Products.
- In-depth knowledge of EU MDR (2017/745) and IVDR (2017/746) regulatory frameworks and technical documentation review.
- Proven strategy for MDSAP readiness, ensuring cross-functional alignment and technical regulatory success.
- Specialized guidance for companies navigating complex compliance issues or enforcement actions.
Preparation
- Audit / Inspection processes, policies, procedures and protocols including roles and responsibilities of staff
- Strategic readiness programs tailored to the demands of the specific type of audit / inspection
- Comprehensive preparation focusing on record completeness and accuracy
- Inspection readiness assessment
- Mock audits
- Document organization and Back-room staging
- Back-room management protocols
- Front-room, Back-room and general personnel training
Services Include:
Inspection Execution and Response
- Management of Back-room activities during an audit / inspection
- Evaluation of nonconformities, observations and any verbal remarks from the auditor / inspector
- Guidance on CAPA planning, root cause investigation, containment activities, corrections and corrective actions
- FDA 483 response and updates
- Notified Body response
- Warning Letter response and planned periodic updates
- Assistance with FDA and other health authority interactions
Remediation
- Comprehensive program and/or targeted area remediation services covering all areas of the Quality Management System
- Project Management and/or program leadership
- Advisory services and guidance to your executive leadership
- Expert staffing to partner with and assist your team during remediation
- Full turn-key solutions, advisory services or targeted staff augmentation
- FDA and other health authority communications
- Program completion assessment and effectiveness check
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