Our Mission

To help our clients succeed by providing them high value-added services

Our Vision

Business Excellence Consulting Inc.

Books published by the American Society for Quality

To be recognized as a premier service company across the FDAregulated industry

Our People

As of December 2012, more than 110 highly qualified professionals are part of our team. Some highlights are:

Why Choose BEC?

Teamwork and comprehensive approach to all our projects Knowledge Expertise Reputation 100% local ownership and resources Proven success as a third-party control Complete services to any project (renting consultants is not our business)

SERVICES INFORMATION

23 engineers 25 licensed chemists 19 master degrees 5 PhD and 1 JD 45 certified as CAPA Experts 49 certifications (ASQ, PMP, RABSA) ALL with extensive experience within the FDA-Regulated Industry Authoring best-selling books and articles

City View Plaza Suite 802 Road 165 Guaynabo, PR 00968 Postal Address PO Box 8326, Bayamon PR 00960-8326
Phone: 787.705.7272 Fax: 787.705.5272

Training CAPA System Support Validations Compliance Audits

Passion for Quality

Pepe Rodrguez-Prez, PhD

President

Your KEY to SUCCESS

email: info@calidadpr.com

Company Overview
Knowledge, devotion for our customers and PASSION FOR QUALITY are the best definitions of Business Excellence Consulting Inc (BEC). His founder, Dr. Pepe Rodrguez-Prez started it in 2005 as a training company and he continues today leading BEC into a fast-growing company serving the medical product manufacturing sector. All major pharmaceutical, medical devices and biotech companies are part of our extensive client portfolio in three continents. In addition to Puerto Rico and the continental United States, we are providing services in Canada, Costa Rica, Dominican Republic, Malaysia, Mexico, Indonesia, Ireland, Singapore, Spain, Switzerland, and the UK.

Training
With more than 60 courses and workshops, BEC is the leading regulatory and compliance training in the Caribbean. BEC provides training in-house or in our training facilities located in City View Plaza, Guaynabo.

Validations

Risk-based validation master plan development and management

Equipment commissioning/qualification: manufacturing, packaging, laboratory, facilities/utilities

GMP education and training CAPA System EXPERT certification Root cause analysis and effective CAPAs Statistical trainings (Statistics with Minitab, Sampling, DOE, Six Sigma Green Belt) Technical an compliance writing Quality risk management Training effectiveness measurement Human error investigation and reduction

Computer system validation for cGMP applications: SCADA, LIMS, BMS, ERP, TRACKWISE, MES, Laboratory electronic notebook

Computerized system validation life cycle: concept, requirements, design, vendor management, procurement, commissioning, qualification/ validation, operation/maintenance, retirement

21 CFR 11 assessment and remediation Quality control laboratory: analytical test method validation, computer system validation, qualification of analytical equipment Qualification/validation package assessments Development of continuous process verification programs aligned with new FDA guidance

CAPA System Support

The most important element to consider when you engage in business with our company is that you will always receive a full service. In addition to our on-site consultants, BEC will provide your company with the regulatory support of our highlyskilled management team. While most of our competitors simply rent you consultants, BEC will always give you a premier consideration, including full-support from our regulatory-savvy management team. To discuss your compliance and regulatory needs and to learn more about our proven track record within the regulated industries, please contact us.

Investigations, deviations, OOS Complaints investigation Retrospective reviews and third-party independent review of CAPA documents

Compliance

Annual product reviews Comprehensive product assessment Change control

Audits

Internal audit 21 CFR 211 Quality system assessment 21 CFR 820 and ISO 13485:2003

Inspection readiness

The quality of our work is our best presentation card

Engaging in business with our company means that you will receive the support of an outstanding group of top-quality professionals. This is our unconditional guarantee.
Pepe Rodrguez-Prez, PhD
President