Focus on Change Control Management in Updating QMS to Include Labeling Needs
1 Hour Video | Chris Kilander, Cook Pharmica LLC
You’ve read the UDI rule, you’ve updated all of your labels, and you’ve submitted your data. Now, how do you stay in compliance? When implementing new requirements into their Quality Management Systems (QMS), manufacturers must ensure that established change control procedures clearly incorporate the new requirements while maintaining the overall efficiency of the QMS. With the new UDI requirements specific to product labels, device and diagnostic corporations must revisit their change control procedures and integrate the appropriate triggers and control mechanisms into their QMS to ensure continued compliance with the new UDI regulation, as well as the Quality System Regulation and the ISO 13485 standard. In addition, manufacturers also need to recognize and comply with the standards defined by their FDA-accredited Issuing Agency with respect to labeling changes that may require new device identifiers and/or database updates.
- Overview of general change control requirements and processes
- Identification of UDI & Issuing Agency requirements for changing labels
- Strategies for managing the downstream impacts of label changes
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Labeling Specialist
- Regulatory Labeling
- Quality Management
Chris has been with various Cook Medical companies since 2003, including roles in Regulatory Affairs, Quality Assurance, and Corporate Compliance. Chris is currently Regulatory Affairs Manager for Cook Pharmica LLC, with a primary focus on IVF media products. He is actively involved in Cook’s global efforts to implement FDA’s Unique Device Identification regulation and the GS1 standards for labeling. He also plays a key role in evaluating and implementing new regulatory and quality policies and regulations, particularly those from FDA. Chris has also served as Quality Assurance Manager for Cook Urological for six years, overseeing all aspects of quality, including internal auditing, supplier qualification, quality engineering, environmental monitoring, quality systems, external audits, end product testing, document control, customer relations/complaint handling, adverse event reporting, and software quality.
Chris is a chemical engineer by education, earning a BS in Chemical Engineering from Rose-Hulman Institute of Technology and a MS in Chemical Engineering from Clemson University. Chris has earned the US and EU Union Regulatory Affairs Certifications (RAC) and is a Certified Quality Engineer (CQE). In addition to his current responsibilities, Chris also serves as an adjunct professor at Ivy Tech Community College, supporting the Regulatory Affairs programs and teaching an introductory course on Food and Drug law.