Stelex in San Juan, PR, US (United States)

We assist regulated industry clients at the executive, management and staff levels by providing best practice advice and implementation expertise in areas related to regulatory compliance, technology and validation. 

Stelex offers complete life cycle validation services for computer systems. We have extensive experience with computerized systems used in manufacturing, quality assurance, document management, RD, and clinical trials among others. 

Jay Allen is a Senior Pharmaceutical Consultant with Stelex. He conducts CGMP and Pre-Approval Inspection (PAI) audits at dosage form and Active Pharmaceutical Ingredients (API) manufacturers, as well as QSR audits at medical device manufacturers. 

This course will cover the basics of Good Manufacturing Practice requirements. The student will acquire a knowledge of the history of the regulations and their enforcement. An outline of the topics covered by 21 CFR Parts 210 and 211 is followed by an in-depth discussion of specific requirements. 

Maximo® Enterprise Suite combines best-in-class asset and service management software solutions to keep your company marching towards its business objectives.