"In today’s modern GMP operations, the difference between success and failure can be quantified in 1s and 0s. The better an organization understands, manages, and leverages its data the potential for success increases exponentially."
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.
Education
- B.S. - Computer Science, Delaware Valley University
Professional Associations
- International Society for Pharmaceutical Engineering (ISPE)
- Parenteral Drug Association (PDA)
Industry Experience
- GlaxoSmithKline
- Sanofi
- Johnson & Johnson
Publications
- Niziolek, John. “IT/OT Convergence: The Path to Pharma 4.0™.” ISPE, March 2021.
- Niziolek, John. “Pharma 4.0 Part 1: Welcome to a Smarter Way of Manufacturing.” IPS Insights, March 2019
- Niziolek, John. “Pharma 4.0 Part 2: The Double-Edged Data Sword.” IPS Insights, March 2019
- Niziolek, John. “Metadata: The Key to Understanding Your Data.” INTERPHEX 2018 Show Daily, April 2018
Presentations
- Niziolek, John. “A New Focus on an Old Problem: Data Integrity in the Modern GXP Process.” ISPE Canada Affiliate Annual Education and Product Symposium, 6-7 May 2019, Toronto, ON.
- Niziolek, John, “Data Security/Data Lockdown.” INTERPHEX, 18 April, 2018, New York City, NY.
- Niziolek, John. “Bringing Life Sciences to the Cloud.” Cornerstone On Demand, June 2014.
