VALID

COMPLIANCE

INC

3712 N Broadway St.

Suite 280

Chicago, IL

312-602-3358

 

David McElhiney

dave@validcompliance.com

Drug / Device Consulting Services – Development, Validation, Implementation

Over ten years of experience in pharmaceutical, biotechnology, and medical device industries.

Exhibits a broad range of knowledge and expertise with emphasis on technical aspects of bringing new products to market and maintaining compliance for approved products.

Specializes in manufacturing scale-up and improvement projects with proficiency in leading and executing validation of cleaning, process, control systems, and equipment.

Superior technical writing ability and expertise in creation and approval of protocols, reports, procedures, master batch records and policies.

Excellent verbal communication cultivates working relationships with all levels of an organization from operators through executives.

Skilled at building interdepartmental management consensus required to integrate novel products and processes into existing manufacturing and quality systems with minimal impact on continuing operations.

Areas of Expertise

·     GMP / GLP / GTP

·     Cleaning Validation

·     Process Validation

·     Equipment Validation

·     Facilities Validation

·     Control Systems Validation

·     Compliance Gap Assessment

·     21 CFR Part 211

·     Proteins / Peptides

·     Small Molecules

·     Vaccines

·     Parenterals

·     Nanoparticles

·     Suspensions

·     Orthopedic Implants

·     21 CFR Part 11

·     Protocols and Reports

·     SOPs

·     Master Batch Records

·     Incident Investigations

·     Corrective and Preventive Actions

·     21 CFR Part 210

·     Project Leadership

·     Training

·     Quality Systems Implementation

·     Change Control Management

·     Operations Management

Selected Highlights

·   Scaled-up nanoparticle pharmaceutical manufacturing process from laboratory to cGMP pilot plant to commercial production while increasing yield 300%

·   Validated equipment, process and cleaning in conjunction with production scale-up

·   Qualified new multi-use human tissue processing facility, controls and equipment

·   Achieved interdepartmental consensus to redesign impractical cleaning validation strategy

·   Reduced operations staff requirement by 50% through delivery of 21 CFR Part 11 compliant PLC/SCADA system

·   Implemented practical cGMP quality system controls and validation master plans for small and midsize manufacturers minimizing impact to operating overhead.

Education

Bachelor of Arts, Chemistry, Wabash College

Clients

Culver Tool and Engineering, Plymouth, IN

2008 – 2009

·   Equipment Validation

·   Control Systems Validation

·   Facilities Validation

·   Process Validation

·  Developed validation master plan for medical device implant production facilities and equipment including CNC precision cutting machines.

·  Implemented policy and procedure improvements to increase control of critical manufacturing operations.

·  Trained client’s validation group on development, execution, and approval of validation and qualification studies.

·  Wrote and executed IQ/OQ/PQ protocols and delivered approved reports.

Petroferm, Gurnee, IL

2008 – 2009

·   Six Systems cGMP Audit

·   Compliance Assessment

·   Process Development

·   Audited current systems and identified critical improvements to upgrade manufacturing capability and expand customer base.

·   Identified equipment and facility improvements, process control enhancements, and quality system requirements.

·   Delivered report detailing recommended improvements to achieve expeditious marketing approval.

Abbott Spine, Austin, TX

2008

·   Compliance Assessment

·   Equipment Validation

·   Control Systems Validation

·   Facilities Validation

·   Cleaning Validation

·  Wrote templates for validation of metal and polymer orthopedic implant production and cleaning.

·  Implemented validation master plans with implant and tool suppliers.

·  Trained validation and quality personnel for client and client’s suppliers.

·  Developed compliance plans for existing products and obtained approvals.

·  Wrote and executed qualification protocols and reports for CNC equipment.

·  Wrote and executed process and cleaning validation protocols and reports.

Northwestern Memorial Hospital, Chicago, IL

2007 – 2008

·   Equipment Validation

·   Control Systems Validation

·   Facilities Validation

·  Wrote and executed IQ/OQ/PQ protocols for new cGMP / cGTP human tissue processing facility and manufacturing equipment.

·  Delivered approved final reports.

·  Developed and coordinated action plans with clients and vendors to resolve validation issues expeditiously while maintaining systems change control.

·  Wrote specifications for process equipment and computer control systems.

·  Assessed Part 11 compliance and implemented procedural controls.

·  Wrote SOPs for control systems, equipment operation, and maintenance.

Sanofi Pasteur, Swiftwater, PA

2007

·   Cleaning Development

·   Process Development

·  Developed and verified cleaning methods for vaccine process equipment.

·  Designed process development studies to support new manufacturing facility start-up.

·  Developed TOC swab and rinse recoveries.

·  Wrote and executed protocols and delivered approved final reports.

American Pharmaceutical Partners, Melrose Park, IL

2004 – 2005

·   Control Systems Validation

·   Equipment Validation

·   Training

·   Designed, validated and installed 21 CFR Part 11 compliant PLC/SCADA process control and monitoring system for nanoparticle manufacturing.

·   Wrote SOPs, master batch records and policies.

·   Wrote and executed validation protocols and delivered approved final reports.

·   Developed and presented training courses and documentation.

·   Provided critical real-time process monitoring and troubleshooting to assure delivery of finished product inventory for aggressive launch schedule.

Employers

American Pharmaceutical Partners, Melrose Park, IL

Formulation Supervisor

2001 – 2004

·   Production Scale-up

·   Process Development

·   Process Validation

·   Cleaning Development

·   Cleaning Validation

·   Equipment Validation

·   Training

·   Deviation Investigations

·   CAPA Implementation

·  Validated and installed equipment, systems, and processes required for scale-up from clinical to commercial production.

·  Developed and validated cleaning procedures for nanoparticle suspension manufacturing equipment.

·  Wrote SOPs, master batch records and policies.

·  Wrote and executed validation protocols and manufacturing studies.

·  Delivered approved final reports.

·  Developed and presented training courses as a company certified Qualified Trainer.

·  Delivered finished product supplies to support Phase I, Phase II, and Phase III clinical trials.

·  Investigated and resolved manufacturing deviations and implemented corrective action.

·  Managed and documented systems change control to minimize impact on continuing operations.

·  Developed operations staffing requirements for new product launch.

·  Hired and trained 30+ operators and supervisors to support 24 hour manufacturing.

Formulation Scientist

2000 – 2001

·   Process Development

·   Product Development

·   Production Scale-up

·   Analytical Chemistry

·  Developed generic parenteral products and achieved regulatory approval prior to innovator patent expiration.

·  Optimized proprietary nanoparticle production process.

·  Wrote product development study protocols, SOPs and NDA/ANDA development summary reports.

·  Performed HPLC and wet chemistry analysis as required to complete product development studies.

·  Reviewed and approved laboratory notebooks and technical reports.

Analytical Chemist

1999 – 2000

·   HPLC Method Validation

·   Analytical Chemistry

·   Performed and validated HPLC and wet chemistry analytical methods.

·   Investigated and resolved out-of-specification results.

·   Evaluated novel analytical methods to resolve procedural gaps and facilitate method transfer.

Reviewed and approved laboratory notebooks.

Eli Lilly, Indianapolis, IN

Biochemist

1997 – 1998

·   Process Development

·   Production Scale-up

·   Analytical Chemistry

·  Optimized laboratory scale protein purification process.

·  Presented research and development data to peers and management.

·  Evaluated novel technologies and transferred to cGMP pilot plant.

·  Performed HPLC and wet chemistry analytical methods.

Laboratory Technician

1995 – 1997

·   Protein Analysis

·   Laboratory Automation

·   Analytical Chemistry

·  Performed and developed HPLC and wet chemistry analytical methods.

·  Maintained HPLC laboratory equipment.

·  Automated analytical scale purification process.