True Validation ‘Ready’ Labeling – What It Really Means
Industry Experts Share Best Practices of Implementing A ‘Validation Ready’ Cloud Based Global Labeling System.
Medical device, clinical trial and pharmaceutical companies cannot afford to take short cuts when validating their labeling systems and processes, they need to be stringent in meeting quality standards during the production process. However, working your way through the validation minefield of what is needed to be compliant is no easy task, and can become an ongoing task that’s time consuming and costly.
No matter the size of company, whether large or small, the principles of validation are the same. Not only are there the initial implementation requirements to meet, but there is also ongoing maintenance of the policies, procedures, qualification document libraries, training and replacement hardware costs to consider.
Many regulated companies are now moving to cloud-based solutions, believing it is the ideal answer. But be aware, different solutions offer different levels of qualification and associated documentation, and only a few are truly ‘validation ready’. Computerized systems that use GxP processes are qualified only when the system can demonstrate its ability to fulfil the strict requirements demanded by GxP standards.
In this 60-minute information packed session, PRISYM ID and supporting experts will share best practices on compliance, what to look for in a ‘validation ready’ cloud-based solution, how to leverage your supplier and how to remove the burden associated with compliance enabling your production team to focus on labeling and production control.
Key Learning Objectives:
- Understand what compliance requirements are needed to be met (including 21 CFR Part 11, Quality system, Annex 11 and ISO 13485 document control requirements).
- Realize how to proactively manage risk by implementing a standardized approach using the GAMP V model.
- Gain an understanding of what you must look for in a cloud based labeling solution to meet validation requirements.
- Know how you can reduce time and make significant cost savings by leveraging cloud-based platforms and your supplier to meet future needs and ongoing maintenance requirements.
MEET OUR SPEAKERS
Phil Dray, Test Manager, PRISYM ID
Phil is Senior Test and Validation Engineer at PRISYM ID, assisting our clients in meeting compliance to FDA, MHRA, EU and GMP regulations for software products supplied to the life science and device industry. He also ensures that validation documentation and processes are in line with current regulatory guidance and delivers training for PRISYM ID’s proprietary software. He provides test plans and processes to ensure software products are robust before release.
Phil started within the electronics industry and moved into computing through field/customer service. He has been with PRISYM ID for over 25 years and has contributed through customer service, installation and customer training. He has extensive experience in software test and process planning.
Stephen Ferrell, Compliance Expert, CompliancePath
Stephen Ferrell is a recognized expert in regulatory compliance in the Pharmaceutical, Medical Device and Biotech space. Stephen was co-founder of CompliancePath Ltd, a compliance services company that support regulated clients globally. He has held executive and senior level management positions with a number of technology firms in the Life Sciences. Stephen has implemented Quality Management Systems at several companies at both the corporate and divisional level and has hosted and conducted countless audits across the GxP disciplines, ISO13485 (inclusive of IEC62304/ISO14971), ISO27001, SOC 1 & 2, EHNAC and FEDRAMP.
Stephen is a trusted advisor to the US FDA, having provided CSV, Cloud and Data Integrity training directly to field consumer safety officers. Mr. Ferrell’s relationships with the US FDA led to the ISPE GAMP IT Infrastructure Control and Compliance Guide being endorsed by CBER, CDER and CDRH as well as the MHRA in the UK.