​Artificial intelligence is rapidly reshaping how life sciences organizations approach quality, validation, and operational excellence. But adopting AI in regulated environments requires more than new tools, it demands new frameworks, guardrails, and ways of thinking.

​In this Career Catalyst session, we’ll explore how AI is evolving from experimental technology to regulated capability. We’ll walk through the history of AI, unpack the FDA’s draft guidance on Computer Software Assurance (CSA), and examine practical frameworks for implementing AI responsibly in life sciences organizations.

​Through case studies, we’ll highlight how companies are already leveraging AI, and we’ll look ahead at the technology roadmap shaping the future of digital quality, validation, and manufacturing.

​This session will help you understand how AI is changing the rules and how to prepare for what’s next.

​What you'll learn:

• ​The history of AI

• ​What the FDA’s CSA draft guidance means in practice

• ​How to implement AI responsibly with frameworks and guardrails

• ​Real examples of AI improving compliance and efficiency

• ​The technology roadmap and what the future ahead looks like

​Who should attend this session:

​This session is for anyone responsible for implementing AI in a way that meets regulatory standards, or if you need/want to stay ahead of how AI is transforming the industry.

​About the Host

​​Kayla Britt, M.S.

​​Published scientist and former cell-therapy validation engineer (Kite/Gilead) turned AI validation specialist. I translate context-of-use into acceptance criteria, URS/VP, executed evidence packs, and change-controlled releases—so R&D assistants and GxP-adjacent workflows are not just accurate, but audit-defensible.

​​LinkedIn | Website

​About the Speaker

​Guarav Walia

​Mr. Walia is currently the VP of CSV/CSA/DI and Digital Governance, Head of PQE Group Chicago Office and Local Equity Partner at PQE Group.

​Also he is an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program

​With over 29 years of experience in Pharmaceutical/Medical Device and Consumer Healthcare environment with extensive experience in end to end processes such as Computerized Systems Validation, Computer Software Assurance, Data Integrity, CQV. Cleaning Validation QMS, SDLC, Agile and Waterfall Methodologies, Validation and Qualification (within, IT, Laboratory, Manufacturing for Standalone through Enterprise Systems), IT Policies and SOP generation, review, revision and approval, IT Infrastructure Review and Qualification/Validation and Audit/Documentation, overall Audit/Assessment Execution with GAP Generation and Remediation, Customer and Vendor Audit and Compliance Quality Assurance Compliance and Laboratory Analyses. He also recently has been involved in the areas of Facility design,  Technology Implementation, Cybersecurity, Machine Learning and AI.

​LinkedIn

​About the Program

​Career Catalyst

​Career Catalyst is BioBuzz’s flagship weekly virtual series connecting life sciences professionals with experts and actionable insights. The program runs every Tuesday @ 12 PM EST for approximately 45 minutes:

• ​20-minute expert presentation

• ​25-minute live, open Q&A

​Sessions rotate through four thematic tracks with new experts each week, ensuring content stays relevant for life sciences professionals at every career stage. Each track is community-led and hosted by our Career Community Ambassadors.

​Tracks include:

​➡️ Career Navigation — Networking, skill-building, and strategies to advance your career across all life sciences disciplines. Hosted by Crystal Richards, Principal & Owner, MindsparQ.

​➡️ Research — Deep dives on research and opportunities shaping the life sciences ecosystem and their relevance to your professional growth. Hosted by Gautam Kumar, Postdoctoral candidate, NIH.

​➡️ Biomanufacturing — Insights into the backbone of biotech success, shaping the industry and your career. Hosted by Paris McKenzie, Manufacturing Technician, Longeviti Neuro Solutions.

​➡️ CQV & Validation — Insights into compliance, quality systems, and operational standards that underpin high-performing life sciences organizations and support your professional growth. Hosted by Kayla Britt, Founder & Principal Consultant, Britt Biocomputing.

​Sponsors

​Bio-Trac​

​With over 30 years of expertise, Bio-Trac® workshops have trained more than 17,000 scientists and engaged 300 scientist instructors. Designed by active researchers and open to the scientific community, these workshops equip bench and research scientists with the latest lab techniques and provide training on cutting-edge biotechnology advancements to a global audience across all biotech sectors.

​LinkedIn | Website

​Workforce Genetics

​Workforce Genetics (WGx) is a premier recruiting firm serving the life sciences, MedTech, and healthcare sectors, supporting companies from startup to commercial. The firm delivers transformative talent strategies through retained and executive search, contingent search, and outsourced talent acquisition.

​LinkedIn | Website

​​Important Information

​BioBuzz's Career Catalyst sessions are intended to provide insights, guidance, and support for professionals navigating their careers. These sessions are not a platform for selling services, recruitment pitches, or business solicitations. They are designed for job seekers and those looking to make connections and build community.

​Please be respectful of fellow participants and help ensure this remains a valuable, trusted resource for all.

​Participants who engage in solicitation, promotional activity, or behavior that disrupts the intent of the session will be asked to leave.

​Repeated or serious violations may result in removal from the session and exclusion from future Career Catalyst events.

​Want to be an expert guest?

​If you’re interested in sharing your knowledge with the BioBuzz community, get in touch via hello [@] biobuzz.io.