Erik C. Staley

*** ******** ******* **. *****: 760-***-****

Suite 108A, PMB 107 Fax: 760-***-****

Carlsbad, CA 92008 abo91a@r.postjobfree.com

PROFESSIONAL SUMMARY

Results-driven validation and FDA compliance specialist with over 18 years of experience in the

regulated life science industries.

Extensive project management and hands-on experience in the validation field, with a focus on

validation of computer systems and laboratory instrumentation,

Noted speaker and contributor to industry, excellent communicator, and strong technical writer,

As the leader of two contract consulting firms, effectively managed staff, applied technical

expertise, and drew upon regulatory knowledge so that clients consistently met objectives, such

as obtaining FDA approvals and overcoming regulatory hurdles.

EMPLOYMENT SUMMARY

President / Principal Consultant

Valicom, Inc.

Carlsbad, CA 2002 - present

Presently directing operation of a consulting firm specializing in computer validation and FDA compliance.

Accomplishments include:

Configuring and validating Laboratory Information Management Systems (LIMS), such as Applied

Biosystems / LabVantage SQL*LIMS:

o Developing validation master plans and validating LIMS implementations,

o Validating custom configurations, including database tables and reports, labeling and

barcode systems, and laboratory instrument interfaces,

o Configuring and validating LIMS for QC (GMP) and Clinical (GLP/GCP) laboratories,

Performing gap analyses and risk assessments (GMP, GLP, GCP, 21 CFR Part 11, and HIPAA),

Developing a comprehensive computer system and instrumentation validation package that a

laboratory equipment vendor sells to its customers,

Developing and maintaining GAMP lifecycle documentation, including user requirement

specifications, functional specifications, risk assessments, and traceability matrices,

Validating Electronic Document Management Systems (EDMS), such as Open Text s LiveLink,

Designing and validating custom applications, databases, and spreadsheets,

Upgrading, configuring and validating networked chromatography equipment (HPLC, GC, and

CE), such as Agilent s ChemStation / ChemStore and Waters Empower,

Auditing vendors and suppliers for GxP and HIPAA compliance, including comprehensive

technical and compliance audits of software vendors, datacenters, and ASPs,

Developing QSR-compliant quality systems for device / diagnostic manufacturers, and

submission of regulatory filings,

Establishing clients compliance with HIPAA, including crafting security and privacy policies and

procedures, and development of business associate agreements,

Selecting and managing staff.

Valicom s clients have included Genentech, Biogen Idec, Abbott Laboratories, Aperio Technologies,

Ambry Genetics, SkyePharma, Anadys Pharmaceuticals, De Novo Software, Innovative Cell

Technologies, and the John Wayne Cancer Institute

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Principal Consultant / Co-Owner

CPK Validation Services

Lake Forest, CA 1998 2002

Directed operation of a validation consulting firm.

Configured and validated networked chromatography data systems,

Validated other computerized laboratory equipment, such as spectrophotometers, spectrometers,

and automated in-process test equipment,

Completed 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems,

including remediation and validation of deficient systems,

Presented validation work to FDA inspectors during PAIs and GMP inspections,

Developed and validated custom spreadsheets,

Directed cleaning validation studies, including development of sampling techniques, validation of

trace level analytical methodology, preparation of SOPs, assignment of limits, and presentation of

results,

Completed process validations: Characterized critical process parameters, designed and

reviewed protocols, supervised sampling activities and analyses, and prepared summary reports,

Completed IQ, OQ, and PQ of manufacturing equipment, such as tablet presses, sterile filling

lines, mixing equipment, packaging lines, autoclaves, incubators, labeling and barcoding

systems, and organic synthesis equipment,

Prepared SOPs describing validation policies, change control procedures, and equipment

operation.

CPK s clients included IDEC Pharmaceuticals and Celltech Pharmaceuticals (formerly Medeva

Pharmaceuticals CA).

Sr. Quality Engineer

B. Braun McGaw

Irvine, CA 1995 1998

Completed validation projects and developed quality plans for a manufacturer of medical devices and

injectable drug products.

Developed validation master plans, IQ, OQ, and PQ protocols, and summary reports,

Validated computerized test systems, manufacturing facilities, process utilities, and

manufacturing equipment,

Coordinated the activities of engineering, QA, QC, and contract staff,

Selected and managed consultants,

Designed studies to troubleshoot and improve manufacturing processes,

Developed sampling plans, specifications, and SOPs,

Audited suppliers and presented findings.

Process Engineer

Canon Business Machines

Costa Mesa, CA 1994 1995

Responsible for implementation of quality plans for new products and improvement of existing processes.

Developed chemical test methods and established material and process specifications,

Implemented statistical process control (SPC) techniques to monitor operations, and employed

design-of-experiment (DOE) techniques to optimize operations,

Established an ISO-compliant document control and specification management system.

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Quality Control Supervisor

Techniclone International

Tustin, CA 1994

Managed QC Chemistry and QC Microbiology laboratories for a monoclonal antibody manufacturer.

Audited laboratory operations and brought laboratories into compliance with GLP,

Supervised laboratory staff,

Developed and validated analytical testing methods and prepared related SOPs.

Analytical Chemist

Gensia Laboratories, Ltd.

Irvine, CA 1991 1993

Fulfilled technical service and validation support functions for a manufacturer of small-volume injectable

drug products.

Validated a computerized chromatography network,

Developed cleaning validation techniques; validated cleaning processes,

Investigated manufacturing deviations, recommended corrective actions, and prepared related

technical reports,

Selected a LIMS for use with the Quality Control and Development laboratories; completed

SQL*LIMS Key User training,

Validated analytical test methods,

Assisted with ANDA preparation.

Research Associate

Kendall - McGaw

Irvine, CA 1990 1991

Performed analytical chemical testing to support the development of new injectable drug products and

medical devices.

Quality Control Technician

Teledyne Battery Products

Redlands, CA 1988 1989

Performed chemical testing on lead-acid battery components as part of a university work-study program.

EDUCATION

BS Chemistry, BS Biology: University of Redlands, Redlands, CA, 1990.

Additional coursework in computer science and electrical engineering.

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INDUSTRY CONTRIBUTIONS

Presented Strategies for Efficient and Economical Validation of Laboratory Equipment and

Current FDA Inspection Trends for the Analytical Laboratory at the Laboratory Equipment

Qualification & System Validation Conference, Boston, MA, September 2007.

Presented Successfully Designing and Validating LIMS for the Regulated Medical

Industries at the 6th Annual Laboratory Instrumentation Validation and Qualification Conference,

Chicago, IL, April 2003. Panelist in the Attaining FDA Compliance with Your Validation and

Qualification Program session.

Chaired the 5th Annual Laboratory Instrumentation Validation and Qualification Management

Conference, April 2002, Philadelphia, PA. Taught Validation of Laboratory Spreadsheets

course.

Presented Validation of Steam and Process Gases for Biotech Products at the Validating

Utilities conference, Philadelphia, PA, January 1999.

ADDITIONAL CAPABILITIES

Familiar with implementation, use and administration of database applications.

Proficient with the Microsoft Office application suite (Access, Word, Excel, PowerPoint, Visio) and

advanced uses of these applications for development and maintenance of validation and

compliance documentation.

Language skills:

Spanish, moderate capability, spoken and written.

Portuguese, moderate capability written, basic capability spoken.

Attained ASQ Certified Quality Engineer (CQE) certification in 1997.

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