Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jón Bergsteinsson
Understanding the standard is essential
Stephanie Ojeda
The FDA’s new QMSR will harmonize with ISO 13485 for medical device quality management
Steve Thompson
An excellent technological tool that improves quality and compliance
Kelley Jacobsen
Amid rising prices, medical device supply chains need greater scrutiny and standardization
Jennifer Chu
Findings point to faster way to find bacteria in food, water, and clinical samples

More Features

FDA Compliance News
Streamlines annual regulatory review for life sciences
Facilitates quick sanitary compliance and production changeover
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity

More News


FDA Compliance

IVT’s Validation Week 2018

An invite from Alcon Laboratories

Published: Thursday, September 6, 2018 - 16:25

(CBI UBM: Burlington, MA) -- IVT Network, the trusted source for life sciences validation and compliance knowledge, is featuring its flagship event, the 24th Annual Validation Week Oct. 22–24, 2018, in San Diego. Melanie Demakis, IVT’s senior conference producer, recently worked with Connie Hetzler, conference chairperson and global head of validation, manufacturing science, and technology at Alcon Laboratories, a division of Novartis, to discuss her participation and insight into this event.

“As a global head of validation, I know how valuable attending informative training seminars is for the success of my team,” says Hetzler. “This year, as we have for many years past, my team will be attending IVT’s 24th Annual Validation Week, where we will gain knowledge on all aspects of validation and quality, including process, facilities, computer software, and cleaning validation as well as maintaining data integrity compliance and improving quality systems.

“I highly encourage colleagues to take a look at this year’s full agenda, which includes three FDA presentations, 40 educational breakout sessions, and 32 subject matter experts on the speaking faculty. My team looks forward to exchanging perspectives with their peers, especially as there is already participation from over 100 industry professionals.”

Some of the content highlights featured at this year’s validation week include:
• Insight from the FDA Office of Regulatory Affairs: Learn from recent inspections to increase efficiencies and decrease violations
• Optimize cost reduction in process validation using a risk-based approach
• Establish a site-wide or enterprise-wide data governance program to ensure data integrity
• Bring your own challenge workshop
• Bulletproofing your CSV program: Where to start and how to build for success
• Fireside chat: Innovations in validation systems and quality culture

With more than two decades of experience in validation training, IVT Network organized a well-rounded program and makes it easy to select the sessions that best suit your training goals by identifying track topic, learning level, and industry focus.

“I hope colleagues will register to attend Validation Week to join me and my fellow speaking faculty from the FDA, AstraZeneca, Medtronic, Bausch + Lomb, Shire plc, Alexion Pharmaceuticals, Upsher-Smith and many more,” says Hetzler. “We look forward to welcoming you and learning from one another to improve our validation processes.”

For more information about the event please visit www.cbinet.com/valweek.


About The Author

CBI UBM’s picture


CBI, a division of UBM Americas, is the life sciences industry leader in providing thought leadership, actionable data, benchmarking, case studies and regulatory information through a dynamic conference platform that facilitates innovation, collaboration and elevation across the pharmaceutical, biotechnology, medical device and healthcare industries.