The FDA has been promoting a paradigm shift in systems compliance recently, with the goals of improving systems quality and realizing opportunities for process optimizations. CSA has been "the talk of the industry" for years, yet sometimes organizations struggle to develop expert understanding and deploy real-life practical implementations of the CSA concepts. This session will dispel the "mystery" of CSA, cover the historical factors behind the CSA publication, confirm what CSA is and what it is not, review the core principles, and provide practical steps towards CSA adoption. Bring your questions!
Moderator:
John Niziolek; IPS
Mr. Niziolek is an innovative and creative professional with over 20 years of management and working experience in commissioning, qualification and validation of pharmaceutical, laboratory, clinical and research and development facilities. His experience includes strategic and practical application of regulatory principles for computerized systems, data integrity, infrastructure, cloud computing, equipment, production controls, and automaton platforms for clients.
His regulation and standards knowledge include 21 CFR Part 210, 211,11, 820; 27 CFR; 40 CFR, USP 1058; EudraLex Volume 4 Annex 11; NUPIC; ISO 13485, 27001; SOX; EN 285; GAMP; cGxP; ASTM E-2500-07 (C&Q); Milspec; DOD; HIPAA; Joint Commission; FedRamp and GDPR.
At IPS, John is responsible for the development and growth of the computer systems validation (CSV), data integrity (DI) and medical gases practices. John’s deep understanding of regulated industry and application of regulatory guidance fosters corporate credibility and ensures defensible, compliant project outcomes.
Presenter:
Paul Labas
Paul Labas has been working in the regulatory systems compliance space for about 25 years, since the release of 21 CFR Part 11. Throughout his career, he has worked with a number of large pharmaceutical companies, as well as smaller regulated organizations and industry consultancies. Paul has experience with all relevant aspects of computerized systems quality and compliance, including defining governing procedural frameworks, data integrity, risk-based approach to validation, cloud computing, vendor management, and more. Paul is a regular presenter at industry conferences (including those attended by FDA personnel), and has relevant and recent experience implementing FDA CSA principles at multiple companies.
https://www.linkedin.com/in/paullabas/
Registration will open at 5:30 pm and appetizers/drinks (wine and beer) will be served beginning at 5:30 pm; the presentation will begin at 6:30 pm and conclude by 8:00 pm.
"WALK-INs" will be accepted the night of the event, with a $20 surcharge per ticket type (PayPal, cash and credit card will be accepted).
Schedule of Events:
- 5:30 pm – 6:30 pm: Appetizers, Cocktails, Networking
- 6:30 pm – 8:00 pm: Presentation and Q&A
- 8:00 pm – 8:30 pm: Socializing & Meeting Adjourned