TAMPA, FLa.--(BUSINESS WIRE)--Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced it will present a live webcast this week on how medical device organizations can prepare their Quality team and their Quality Management System (QMS) for a successful ISO 13485:2016 assessment. This will be the fourth in a 4-part series presented by Pilgrim on the newest version of the ISO 13485 regulation.
The webinar, The Ultimate Guide to ISO 13485:2016 Audit Readiness, on October 11, 2017, will be presented by Cynthia Lambert, Regulatory Specialist at Pilgrim Quality Solutions. Ms. Lambert will provide expert advice on how to prepare for this critical assessment, helping attendees get a handle on team training needs, auditee etiquette, and the quality system data they should have on hand to be audit-ready.
“An assessment is your unique opportunity for you to tell your story,” Ms. Lambert says. “In essence, you are communicating and demonstrating how you run your business within the framework of your QMS.
“So when one considers the numerous QMS processes being impacted by the latest version of the ISO 13485 standard, as well as the now-required application of a risk-based approach to those processes, there is an urgency to preparing for the inevitable assessment.” The new ISO standards take effect for new products in March 2018, and for all others by March 2019.
During the webinar, Ms. Lambert will address the updates to ISO 13485, including the QMS processes impacted. She will also discuss the revised standard’s expectation that medical device manufacturers apply risk management methods and techniques to all QMS processes, including outsourcing.
To conclude the session, Ms. Lambert will provide attendees key actionable takeaways for audit success.
Pilgrim Quality Solutions is the leader in quality compliance management software and services for Life Sciences. For more than 20 years, our solutions have automated thousands of processes across global company sites to manage the quality and compliance of life’s most important products. Our cloud-based and on-premise solutions include in-the-box best practice workflows, document and process management, dashboards, electronic signatures, audit trails, and automated validation – helping companies more easily achieve quality system compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.