Improve GxP Audit Coverage and Reduce Compliance Risks
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About this webinar
GxP internal audits often require quality teams across the life sciences industry to balance the depth of their assessments with the need for comprehensive coverage. Traditional approaches may involve rotating audit priorities annually, potentially leaving compliance gaps unidentified in areas receiving less attention. This webinar explores how evidence-based planning and risk-based strategies can improve audit coverage while making more effective use of limited resources in regulated life sciences environments.
Attendees will learn how to evaluate quality system evidence before the opening meeting, identify and prioritize compliance gaps and develop risk-weighted audit agendas. The featured speakers will also discuss how to allocate auditor time to activities requiring human judgment and translate audit findings into timely remediation efforts that support ongoing GxP compliance.
Additionally, the webinar will explore opportunities to integrate artificial intelligence (AI) into audit workflows, including identifying activities suitable for automation and determining where human oversight remains essential.
Register for this webinar to learn how to strengthen GxP audits through evidence-based planning, risk prioritization and more effective remediation strategies.
Who should attend
- Chief Quality Officers
- Heads and VPs of Quality Assurance
- Quality Assurance Directors
- Quality Systems Directors
- Heads and VPs of Regulatory Affairs
- Regulatory Affairs Directors
- Quality and Regulatory Compliance Directors
- Heads and Directors of Quality and Regulatory Affairs
What you will learn
- Rethink the coverage-versus-depth trade-off and make deliberate, defensible decisions about where to spend limited audit hours
- Sequence an audit around evidence, not last year’s plan, by assessing the quality system before the opening meeting
- Build a risk-weighted audit agenda from where gaps cluster, including how to treat areas that would historically have waited for next year
- Apply AI effectively and identify checks that still need human review, such as missing records, high-level regulatory mapping and colliding documents
Featured Speakers
Sumatha Kondabolu
Sumatha Kondabolu brings over 23 years of global quality and regulatory expertise across the pharmaceutical and medical device industries. A global speaker and international standards leader, she specializes in quality systems, regulatory compliance, AI governance and emerging technologies, translating complex global requirements into practical strategies for organizations.
Sumatha has built and managed quality management systems meeting the requirements of FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS and the EU MDR and IVDR, as well as pre-clinical and clinical frameworks. She has supported organizations in establishing robust quality systems aligned with global standards and successfully navigating ISO and regulatory audits.
Sumatha holds a Bachelor of Pharmacy, a Master’s in Chemistry and an Advanced Certificate in Quality Assurance Management. She is a certified auditor for ISO 13485, ISO 27001, ISO 27701, ISO 42001, ISO 22716, ISO 17025, ISO 9001 and IATF 16949.
Beyond her professional role, Sumatha contributes to international standards development and professional communities. She serves as Chair of CSA Z289 and Chair of the Canadian Mirror Committee for ISO/TC 210, focused on quality management and related general aspects for products for health purposes, including medical devices. She also contributes as an expert to ISO/IEC JTC 1/SC 27 in information security, cybersecurity, privacy protection and IEC TC 65/SC 65.
She is also Co-Chair of the International Society of Pharmacovigilance (ISoP) Medical Devices Special Interest Group and Vice-Chair of the RAPS Quebec Local Networking Group. As an international speaker, she regularly contributes to global discussions on medical devices, quality and regulatory science, artificial intelligence, digital health and emerging technologies.
Meg Sinclair
Meg Sinclair is a Quality, Information Security, Privacy and AI Governance leader with over a decade of experience building scalable, audit-ready systems for regulated start-ups and fast-growing SaaS and medical device companies. As Senior Manager of Quality at Qualio, she works at the intersection of systems, people and risk, leading the company’s integrated management system across quality, information security, privacy and artificial intelligence.
At Qualio, Meg serves as management representative for ISO 9001, 27001, 2770 and 42001, overseeing the company’s audit program, internal and external certification audits and CAPA and change management. Before Qualio, she led quality assurance for a Class II medical device manufacturer and spent several years in quality assurance leadership supporting healthcare and insurance technology organizations.
Meg holds a BSc in Health Sciences from San Diego State University and is trained and certified across ISO 9001, 13485 and 42001 and is currently pursuing additional certification in AI governance. She also hosts Qualio’s “From Lab to Launch” podcast, where she and guests unpack what it actually takes to bring regulated products to market. Her approach throughout stays the same: keep the complex simple and elegant, so quality and compliance enable good work rather than get in its way.
Partner for this event
Qualio
Founded in 2012, Qualio is the agentic quality and regulatory compliance platform for life sciences. It unifies quality management, product lifecycle, and regulatory intelligence in a single system, replacing fragmented point tools, manual workflows, and reactive audit prep. Teams use Qualio to accelerate regulatory milestones and product development velocity, while reducing the risk of costly findings and recalls. Qualio is ISO 27001-, 42001-, 9001-, and 27701-certified, reflecting our commitment to the highest standards of security, quality, and privacy.