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Business
Excellence
Consulting Inc.
Why Choose BEC?
Teamwork and comprehensiveapproach to all our projects
Knowledge
Expertise
Reputation
100% local ownership andresources
Proven success as a third-partycontrol
Complete services to any project
(renting consultants is not ourbusiness)
Training
CAPA System Support
Validations
Compliance
Audits
City View Plaza Suite 802
Road 165 Guaynabo, PR 00968
Postal Address
PO Box 8326, Bayamon PR 00960-8326Phone: 787.705.7272 Fax:
787.705.5272
Pepe Rodrguez-Prez, PhDPresident
Your KEY to SUCCESS
Our MissionTo help our clients succeed byproviding them high
value-addedservices
Our VisionTo be recognized as a premierservice company across
the FDA-regulated industry
Our PeopleAs of December 2012, more than 110highly qualified
professionals are partof our team. Some highlights are:
23 engineers
25 licensed chemists
19 master degrees
5 PhDand 1 JD
45 certified as CAPA Experts
49 certifications (ASQ, PMP,RABSA)
ALL with extensive experiencewithin the FDA-Regulated
Industry
Authoring best-selling books andarticles
SERVICESINFORMATION
email: [email protected] Passion for Quality
Books published by the American Society for Quality
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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, PhDPresident
The most important element to consider when youengage in
business with our company is that youwill always receive a full
service. In addition toour on-site consultants, BEC will provide
your com-pany with the regulatory support of our highly-skilled
management team.
While most of our competitors simply rent youconsultants, BEC
will always give you a premierconsideration, including full-support
from our regu-latory-savvy management team.
To discuss your compliance and regulatory needsand to learn more
about our proven track recordwithin the regulated industries,
please contact us.
The quality of our work is ourbest presentation card
Training
With more than 60 courses and workshops, BECis the leading
regulatory and compliance trainingin the Caribbean. BEC provides
training in-houseor in our training facilities located in City
ViewPlaza, Guaynabo.
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
CAPA System Support
Investigations, deviations, OOS
Complaints investigation
Retrospective reviews and third-party inde-pendent review of
CAPA documents
Compliance
Annual product reviews
Comprehensive product assessment
Change control
Validations
Risk-based validation master plan development
and management
Equipment commissioning/qualification: manufac-
turing, packaging, laboratory, facilities/utilities
Computer system validation for cGMP applica-
tions: SCADA, LIMS, BMS, ERP, TRACKWISE,
MES, Laboratory electronic notebook
Computerized system validation life cycle: con-
cept, requirements, design, vendor management,
procurement, commissioning, qualification/
validation, operation/maintenance, retirement
21 CFR 11 assessment and remediation
Quality control laboratory: analytical test methodvalidation,
computer system validation, qualifica-tion of analytical
equipment
Qualification/validation package assessments
Development of continuous process verificationprograms aligned
with new FDA guidance
Audits
Internal audit 21 CFR 211
Quality system assessment 21 CFR 820 and ISO
13485:2003
Inspection readiness
Company OverviewKnowledge, devotion for our customers andPASSION
FOR QUALITYare the best definitions ofBusiness Excellence
Consulting Inc (BEC). Hisfounder, Dr. Pepe Rodrguez-Prez started it
in 2005as a training company and he continues todayleading BEC into
a fast-growing company serving themedical product manufacturing
sector.
All major pharmaceutical, medical devices andbiotech companies
are part of our extensive clientportfolio in three continents. In
addition to PuertoRico and the continental United States, we
areproviding services in Canada, Costa Rica, DominicanRepublic,
Malaysia, Mexico, Indonesia, Ireland,Singapore, Spain, Switzerland,
and the UK.
