21 CFR Part 11 and QMS Software Risk-Based Implementation Recorded Webinar | John E Lincoln | From: Sep 03, 2021 - To: Dec 31, 2021 |
CGMP-compliant companies must develop/implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records/signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
Areas Covered in the Webinar:-
Frequently Asked Questions:-
Why Should You Attend:-
Software/firmware design, development, testing/verification, and validation, implementation, and usage are difficult to structure, manage, document and control, especially in the QMS with Pt. 11. For many companies, the subject can be intimidating. Software and firmware used in a regulated industry are under increased scrutiny by the U.S. FDA and is a growing concern by all regulatory agencies worldwide. Quality Management Systems are heavily software/firmware driven in today's manufacturing, with the added concerns of 21 CFR Part 11 (Annex 11 in the EU), data integrity, and cybersecurity.
A comprehensive, corporate-wide plan, accompanied by proper implementation and use of a defined life-cycle, and documentation, is a necessity. Growing "cloud" issues add urgency to upgrade control. Regulatory requirements also demand a product risk-based approach. And there’s IEC 62304 and GAMP(reg.) 5. What are the best practices? How can tougher regulatory (FDA and EU) expectations be met? What implementation and control is necessary to minimize software failures or breaches? How to use the FDA's own "model" to document SW V&V. This systematic approach also adds predictability (time and budget) to software development, implementation, use, and decommissioning.
The US FDA requires that all devices, production/test/lab equipment, and processes, especially the QMS, using software/firmware be implemented, used, and validated according to strict requirements. Similar for the EU. This presentation focuses on the planning and execution of system-level software documentation, implementation use, and verification/validation, after basic developmental testing and debug. With the focus on QMS and Part 11 requirements, including data integrity and cybersecurity. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software.
A suggested FDA model (mandated for submissions), that has been field-tested for over 20 years, is also defined, evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software issues considered are primarily QMS and 21 CFR Pt. 11. What are the data integrity and cybersecurity issues? How to determine risk-based. Related IEC 62304 and GAMP(reg.) 5 concerns.
Who Will Benefit:-
From the following Industries:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
