About IVT's Computer Systems Validation Event of the Year's Technical Advisors...




Erik Muegge, Assistant Director, R&D Technology Compliance, Alcon Laboratories 

Erik Muegge has been with Alcon for 15 years.  He is currently the head of the R&D Technology Compliance Department.  Responsibilities of this department include setting policy, helping the users for all types of implementations, leading onsite audits of vendors, and managing several common enterprise computer systems including LIMS, R&D’s chromatographic data system, R&D’s document management system, and the laboratory data archive system.  His work experience has included methods development, global regulatory submissions, laboratory automation, compliance manager, and computer validations.  Erik’s computer system validations range from individual laboratory systems, to enterprise systems as well as building automation systems.  The validations in which Erik has been involved have successfully passed audits by the FDA and other regulatory bodies.  He has presented at numerous conferences internationally on the topics of validation, compliance, and laboratory automation.  He was the recipient of the 2003 IVT Presenter of the Year award.  Erik has both a bachelor and master’s degree in chemistry and is a certified Project Manager.

Vimarie Ortiz, Operating Partner, Processo Partners, Inc.

 Vimarie Ortiz is a principal with Processo Partners, Inc., a consulting software quality company in South   
 Florida specializing in all aspects of software quality and computer systems validation.  Ms. Ortiz's   experience  
 in the medical devices, biotechnology, and pharmaceutical industry spans a decade, assisting clients in the 
 assessment, implementation, management and training of computerized systems validation, and the design of 
 validation solutions using risk management, lean software development, and configuration management 
 approaches.  For more information, visit www.processopartners.com, or contact by email at 
 vortiz@processopartners.com.