The FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries.

Discussion points include:

• The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner.


• The complexities and confusion surrounding QMS integration post-merger or acquisition, emphasizing the importance of clear SOP adherence and SME identification.


• The strategic development of an inspection readiness playbook outlining detailed procedural actions for audits, including preparation of SMEs and document management.


• Common gaps in the QMS, such as inadequate design controls and insufficient risk management, and the critical area of supplier management, where many organizations struggle to maintain quality audits and qualification programs.


• The distinction between R&D and commercial suppliers, underscoring the need for early and comprehensive qualification processes to mitigate commercialization risks.

Divya's top 5 takeaways:

1. Implement an Inspection Readiness Playbook: Develop a comprehensive playbook that details all aspects of audit preparation, from SME preparation to document retrieval, to streamline the inspection process.


2. Address Post-Merger QMS Integration: Carefully plan and execute the integration of disparate QMSs following mergers or acquisitions to ensure clarity in SOP adherence and effective SME role allocation.


3. Conduct Mock Inspections Regularly: Utilize mock inspections to test the effectiveness of the inspection readiness playbook, identifying and rectifying any gaps in readiness.


4. Focus on Supplier Management: Establish rigorous qualification and ongoing monitoring programs for suppliers, differentiating between R&D and commercial suppliers to ensure quality and compliance.


5. Adopt the PDCA Cycle for Continuous Improvement: Implement the Plan-Do-Check-Act methodology to manage QMS elements, ensuring robust inspection readiness and fostering a culture of continuous improvement.

Divya is a performance-driven and hands-on Quality leader and professional with extensive experience in the medical device and combination product industry. She has contributed significantly to quality management systems, product development lifecycle, risk management, quality compliance, quality management review, inspection management, training, change controls, supplier management, complaint management, and technical operations.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/