Auditing Stability Programs
WebinarA significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and [...]
Preventive Maintenance and Calibrations- Regulatory Expectations and Best Practices
Unlock the keys to regulatory compliance and operational excellence with our 'Preventive Maintenance and Calibrations - Regulatory Expectations and Best Practices' training. Tailored for professionals in FDA-regulated industries, this comprehensive workshop delves into the critical components of effective preventive maintenance and calibration programs. Explore the nuances of cGMP requirements, understand the importance of proactive maintenance, [...]
Digitalization of the Stability Function
Join in this hour of exploring the ups, down, ins and outs of digitalizing your Stability Operations from the viewpoints of a key provider and experienced Stabilitarians.
Video of StabilityHub Office Hours – October 2024
VirtualOn Thursday, October 17, 11:15 am - 12:45pm ET, industry experts gave a 90-minute online discussion, benchmarking, and Q&A session. Participants dropped in and out as schedules dictated to gather information on a broad range of stability topics. This event was hosted by John O’Neill, Walter Routh, and several Subject Matter Experts and sponsored by [...]
Stability Operations for Drugs, Biologics, and Medical Devices
VirtualThis accredited 3-part series on Stability Operations for Drugs, Biologics, and Medical Devices will give you a rock-solid base for establishing or expanding your stability operations knowledge. The focus will be on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs [...]
Collaborative Stability Testing: Speed, Savings, and Success
VirtualA KENX and PSDG Collaboration: Team up to transform your Stability program for faster turnaround, lower costs, fewer errors, and reduced compliance issues. What you need to know about the Stability Laboratory/Operations/Stakeholder Paradigm to boost efficiency, reduce costs, and improve compliance. The Medical Product Stability function is often configured in 3 divisions: The Stability Group [...]
Extractables and Leachables, West 2024
La Jolla, CA La Jolla, CA, CA, United StatesEnsuring Quality, Safety, Suitability and Regulatory Compliance for Drugs, Biologics and Medical Devices