Are you looking to learn more about electronic quality management systems (eQMS) and regulatory affairs solutions? Attend this webinar for an introduction to the critical intersection of regulatory affairs and eQMS solutions in the life sciences industry.
Regulatory information management is paramount in ensuring the core goals of regulatory compliance and market access for products as well as addressing initiatives in transparency, digital transformation and supply chain optimization.
In this webinar, the expert speakers will discuss key considerations and best practices to seamlessly unify regulatory affairs and quality management into one interconnected system.
They will delve into the essential requirements of a regulatory information system and how these connect with eQMS requirements to enhance compliance and operational efficiency. Moreover, industry best practices for unifying regulatory affairs and quality management into one interconnected system will be presented using a practical use case that underscores the importance of alignment between regulatory and quality teams. The speakers will discuss how a comprehensive approach aims to foster a more cohesive and effective regulatory and quality management strategy within organizations.
Register for this webinar today to gain insights into the integration of regulatory affairs and eQMS solutions.
Speakers
Beverly Gavia, Senior Implementation Consultant, Dot Compliance
Beverly Gavia is a seasoned professional with over 15 years of experience in the medical device industry, having held pivotal roles in implementation, product development and management, quality assurance and regulatory affairs. Her expertise in global medical device risk management is underpinned by her background as a licensed laboratory and radiology imaging technologist in Canada.
Beverly has been instrumental in pioneering the establishment of pre- and post-market risk management processes at two prominent medical device companies. Additionally, she has successfully managed and implemented quality process improvement projects, seamlessly integrating multi-site, international teams to drive efficiency and ensure compliance across diverse regulatory environments.
Message Presenter
Yasmín E Cherie, Manager of New Product Introductions, Dot Compliance
Yasmín E Cherie is a seasoned professional with 19 years of experience in the regulatory sector with additional experience within quality, clinical, medtech and commercial, specializing in the life sciences, cosmetics, consumer goods and chemical industries. Throughout her career, she has excelled in various roles within consulting, software implementation, product development, presales and global regulatory affairs.
Currently, Yasmín is the Manager of New Product Introductions at Dot Compliance, where she leads implementations of QMS Xpress and Regulatory Information Management systems, along with providing subject matter expert advisory services for new product development.
Yasmín holds a Bachelor of Business Administration/HR Management from Messiah University and a Project Management Certification from Cornell University. She is a certified Regulatory Affairs Professional and a member of various industry organizations, including PMI, RAPS and DIA. Yasmín’s dedication to continuous learning and process improvement has made her a trusted advisor and leader in her field.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields:
- Regulatory affairs and operations
- Quality systems and control
- Project management
- Digital transformation
- Information technology
What You Will Learn
Attendees will learn about:
- The intersection of regulatory affairs/operations and quality management responsibilities in the life sciences
- The essential requirements of a regulatory information system and how those requirements connect to quality management system requirements to enhance compliance and operational efficiency
- The ways in which overlapping regulatory and quality system requirements can jointly advance transparency, digital transformation and supply chain optimization initiatives
- Industry best practices to seamlessly unify regulatory affairs and quality management in one interconnected system through a practical use case highlighting the importance of alignment between regulatory and quality teams
Xtalks Partner
Dot Compliance
Dot Compliance is the first ready-to-use, AI-powered eQMS for Life Sciences. Packed with generative AI capabilities, Dot Compliance’s eQMS enables medical device manufacturers, biotechnology, and pharmaceutical companies to deliver to market quickly and cost-effectively. Dot Compliance is trusted by many life sciences companies worldwide and is fully compliant with 21 CFR part 11, EU-Annex 11, and supports ISO 9001, 13485, 14971, and 27001. Visit https://www.dotcompliance.com/.
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