For quality teams in life science organizations, implementing the best ways to prepare for and pass internal and external audits can be challenging. Getting everything prepared for an audit is a necessary, yet daunting task. While there is no one way to approach an audit, our experts will help answer common questions about audits to help you feel more confident.
Register for this webinar to hear from leading Quality experts at Qualio, Aytu BioPharma and Cirris to gain an understanding of the best ways to approach and pass an audit.
While we will be using Qualio eQMS as our platform, the principles and strategies can be used regardless of your chosen QMS (Quality Management System). Two of the panelists recently led Qualio through an ISO 9001 certification with zero errors. They will discuss what to do before, during and after an audit, including important topics such as:
- How to operationalize addressing findings with your team internally
- What level of access to give auditors as well as how to answer their questions
- What does the rest of the organization (outside the quality team) need to know or do in advance of the audit
- Many more pro tips
Kelly Stanton, Director of Quality, Qualio
Kelly brings over 20 years of experience in both the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems and is an advisor to over 30 Medical Device and Pharma companies. She is currently the Director of Quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape. She leads a team of talented industry-experienced quality professionals who work with companies in regulated industries on a daily basis.Message Presenter
Meg Sinclair, Senior Quality Specialist, Qualio
Meg has 10+ years as a Quality Assurance, Regulatory Affairs and Compliance professional with a range of cross-functional skills and experience spanning non-profits to start-ups. Meg helps companies adapt to and master new and complex subject material with organization and attention to detail.Message Presenter
Gene Vought, Quality Control Manager, Cirris
Gene has been with Cirris for over 25 years and in the Quality space for over 10 years. Gene has helped Cirris get ISO 9001 certified and the AS9100 certification. Gene has a variety of experience from sales, engineering, manufacturing, product, military and aerospace.Message Presenter
Lisa Helmonds, MBA, Vice President of Quality Services & Operations, MWA Consulting, Inc.
Lisa Helmonds is Vice President of Quality Services & Operations, MWA Consulting, Inc. She has over 30 years of industrial training in the areas of Manufacturing and Quality Assurance in the pharmaceutical, biotechnology and medical device industries. She has extensive GxP knowledge, has worked with several startups and large companies to implement or improve quality systems and procedures, and understands the challenges facing the industry.Message Presenter
Paula Pilecki, Sr. Director, Project and Audit Management, MWA Consulting, Inc.
Paula is the primary contact for clients and associates to schedule and oversee auditing projects and ensure compliance with scheduled timelines and deliverables for MWA audits. She has over 30 years of program and project management experience in both for-profit and non-profit settings and currently focuses on providing superior consulting services to the pharmaceutical, biotech, and medical device industries.Message Presenter
Who Should Attend?
Anyone involved in quality management and/or regulatory compliance, including new start-up founders and executives:
- Quality Management
- Quality Assurance
- Regulatory Affairs
- Clinical Operations
- Product Managers
- Senior Managers
- Clinical Research Staff
What You Will Learn
Join our panel to learn:
- Best ways to prepare for and conduct a thorough internal audit in advance of your external audit
- How to communicate with your auditor before,during and after your audit
- Example of how Qualio used its own eQMS to pass its ISO 9001 audit with zero errors
- Q&A with our experts to get personalized help
Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.