• Reviewed Original BLA Applications and BLA Supplements
  
• Reviewed PMA, 510K and Combination Product Applications
  
• Reviewer of medical device compliance issues from FDA's District Offices and assessed for possible legal action (CDRH)
  
• Reviewed drug product compliance issues from FDA's District Offices and assesd for possible legal action (CDER)
  
• Served as lead Investigator for Pre Approval Inspections (PAI Biotechnology Facilities)
  
• Served as co-Investigator on Surveillance Inspections (Bi Annuals with Team Biologics)
  
• Industry Point of Contact and lead reviewer for Manufacturing Facilities
  Technical Lead on Industry Type C Meetings)
  
• Major contributor to Industry Guidance related to manufacturing and Internal FDA Compliance Program Guidance on inspections
  
• Actively participated in laboratory research at the National Institute of Health (NIH) to support the 21st Century cGMP Initiative.
  
• Working Knowledge of FDA and international guidance documents
  
• Working Knowledge of FDA Regulations applicable to manufacturing or drugs, biotech products, and medical devices
  

• Work experience in Pharamaceutical and Biotechnology Industry
  
• Managed projects for manufacturing and capacity expansion
  
• Experience in translating cGMP regulatory requirements into manufacturing qualification
  Areas of experience and training include Project Management, Manufacturing Facility Qualification (Validation Master Plan writing, IQ/OQ/PQ protocol writing, protocol execution, report and SOP writing)
  
• Experience in quality documentation audits (Annual Report of changes to validated projects, change control, and OOS)
  
• Experience in strategies for development of document control (change control management, management of product and process deviations)
  
• Validated solid dosage manufacturing equipments (chemical reactors, mixers, blenders, coaters, tablet presses, capsulation and robotic filling units, granulators, etc…).
  
• Validated lab equipments (ultrasonic baths, tangential flow filtration units and Filtration testers).
  
• Validated production packaging (tablet and capsule filling, gravimetric powder fillers, labeling etc.)
  
• Validated aseptic process equipments (autoclaves, depyrogenation tunnels, etc…)
  Validated environmental and thermal distribution equipments (incubators, freezers and refrigerators, etc.)
  
• Validated upstream process equipment (Fermenters, centrifuge units, peptone tanks, media prep tanks, etc.)
  
• Validated downstream process equipments (chromatography columns, Filtration Units, etc.)
  
• Validated aseptic filling lines and areas (filling units, media fill studies, environmental conditions, etc.)
  
• Validated barrier technology units (glove boxes, transfer isolators, workstation isolators, etc.)
  
• Validated various critical utilities systems (WFI stills, RO skids, compressed gas systems (carbon dioxide, nitrogen and plant air) and HVAC systems.
  
• Validated process control systems (critical manufacturing utilities)
  
• Working knowledge of Programmable Logic Controllers, DCS and BAS systems
  
• Working knowledge of resource and document management systems such as SAP, LIMS, EDMS and MES.
  

Senior Consultant, Biologics Consulting Group, Inc.
Sunnyvale, CA.

Supervisory Consumer Safety / Compliance Officer, CDER, FDA.

• Served as Team Leader for the Biotechnology Manufacturing Team at CDER's Division of Manufacturing Product Quality in the Office of Compliance.
  
• Managed eight full time reviewers
  
• Responsible for the technical input, delegation and management of regulatory review assignments, center wide meetings, and industry meetings.
  
• Responsibilities included review of CMC sections related to manufacturing facility design, equipment design, and microbiological issues related to product quality for biologics licensing applications (Original BLA, PAS, CBE-30, and AR) and New Drug Applications (NDA).
  
• Served as consult reviewer for CDRH combination products
  
• Served as lead investigator for Pre-Approval Inspections (PAI) conducted domestically and internationally.
  
• Technical lead on Type C meetings for assessment of new and modified manufacturing facilities.
  
• Reviewed establishment reports for compliance issues and gathered pertinent documentation to support legal action recommendations
  
• Industry point of contact for manufacturing facility regulatory requirements
  
• Was active participant in discussions and industry pilot programs for Quality by Design (QbD) and design space.
  
• Instrumental in facilitating the transition of and development of policies for the transferred CBER/CDER biotech products.
• Contributor to the authorship and major revision of the Cooperative Manufacturing Industry Guidance and the Internal FDA Compliance Program Guidance for Pre Approval Inspections and Post Approval Inspections (BLA/NDA).
  
• Instrumental participant in the negotiations and establishment of the future operating state between the Office of Biotech Products and Office of Compliance in terms of CMC review and inspectional responsibilities of biotech products.
  
• Participated in laboratory research at the National Institute of Health (NIH) on projects that support the "Critical Path" initiative. Elements of this initiative involved the challenges in the characterization and manufacturing of a drug product, reduction of supplements, and inspection strategies.
  

Compliance Officer, Office of Compliance in their Division of Enforcement-A,CDRH, FDA

• Responsibilities included reviewing medical device PMA and 510K submissions, and authored documentation for recommendation of medical device recalls.
  
• Reviewed establishment inspection report for compliance issues and gathered pertinent documentation to support legal action recommendations
  
• Represented CDER's Office of compliance as a committee member for planning internal and external FDA events.
  
• Instrumental committee member for establishing the training program for FDA's Pharmaceutical Inspectorate.
  
• Served as committee member for planning the 2008 PDA/FDA conference.
  

Sr. Validation Project Manager, Alza Corporation, Mountain View, CA.

• Developed and implemented qualification strategy for manufacturing facility expansion
  
• Successfully worked with Architectural and Engineering Firms to complete each construction phase and simultaneously generated test plans for capturing facility changes during construction of a new manufacturing facility
  
• Wrote the Validation Master Plan for the qualification of the new facility.
• Wrote design specification for new production equipment.
  
• Executed and generated IQ and OQ protocols for the following solid dosage manufacturing equipments: Manesty Tablet press, Vector Freund Tablet Coater, Glatt Fluid bed Granulators, Lee Industries Pressurized Vessels, Labconco Lyophilization Unit, Hotpak Incubators and Revco Refrigerators, Vector Coulter Ovens, Drying Chamber, Branson Ultrasonic Baths, Pall Tangential Flow Filtration unit, Polymer Mixers, Van der Stahl Heat Sealers, Enercon Induction Sealer, Torque Tester, Transdermal device coating unit, Arrow Solution Mixers, and AHU system.
  
• Performed audits of the validation documents completed by sub contactors for production equipment and facility upgrade.
  
  

Sr. Validation Project Manager, Abgenix, Fremont, CA.

• Wrote and executed IOQ protocols for Fermenters, Filtration Skids, and Media prep vessels.
  
• Worked with the Architectural and Engineering Firm to develop a commissioning strategy for the compressed gas systems: Clean Air, Nitrogen and Carbon Dioxide.
  

Validation Project Manager, Inhale Therapeutics Inc., San Carlos, CA

• Wrote and executed IQ and OQ protocols for equipments used in product stability studies: Humidity chambers by Hot Pack, Environmental Chambers, Glove box/Isolators, Sanyo Refrigerator, Sanyo and Revco Freezers with operating ranges of -80 C to -20 C, RO system, and Preventive and Calibration tracking system.

Validation Project Manager, Penta Biotechnology, Union City, CA.

• Conducted a risk assessment and developed a strategy for qualification of small scale API facility
  
• Successfully managed the qualification activity of the utility systems supporting the manufacturing areas
  
• Verified and amended as-built drawings for the HVAC systems and compressed gas systems.
  

The Validation Company (A Contract Validation Company)
2000 - 2001

Project Manager, Amgen, Inc., Thousand Oaks, CA.

• Wrote IOQ and PQ protocols for autoclaves and bioreactors.
  
• Executed and generated summary reports for an Anatel 643 TOC Analyzer used to provide online data for conductivity and TOC, Nitrogen System by Praxair.
  
• Revalidated existing WFI system.
  
• Validated Aseptic Fill and Packaging Lines.
  
• Aided in the revision of the Validation Master Plan for a manufacturing suite.

Project Manager, Baxter Hyland Immuno, Thousand Oaks, CA.

• Worked with vendors and and Architectural and Engineering Firms to complete qualification of plant utility expansion project
  
• Generated, executed, and authored summary reports for the validation of a US Filter RO system, Meco vapor compression WFI skid and distribution system, HVAC, Ultra Sonic washer and Ozone generator.
  
• Performed controls systems validation on a RO system that utilized an Allen Bradley PLC, BAS system that utilized Siemens PLC and WFI system that utilized an Allen Bradley PLC.
  
• Audited all commissioning documentation provided by system manufactures.
  
  

Sr. Validation Project Lead, Bayer Corporation, Berkeley CA.

• Managed a team of specialists in the generation and execution of aseptic process equipment and facility. Generated IQ, OQ and PQ protocols for the following equipments: Dry heat depyrogenation oven by GruenBerg, Autoclaves by Fedagari and Getinge, Aseptic Fill lines and Packaging line and WFI systems.

Sr. Validation Project Lead, B. Braun Corporation, Irvine CA.

• Wrote and reviewed operational and preventive maintenance SOPs for refrigerators, incubators and Ovens.
  
• Validated the HVAC system of a new manufacturing suite.
  
• Conducted a quality review audit a cGMP gap analysis on existing qualification protocols and SOPs.
  

Sr. Validation Project Lead, Genentech, South San Francisco, CA.

• Performed PQ of LIMS, EDMS and MES systems to support possible Y2K and Synopsis software changes.

Validation Specialist/Project Supervisor, Hoechst-Celanese, Corpus Christi, TX.

• Assisted in cGMP gap and risk assessment analysis of API manufacturing equipment
  
• Assisted in the development of a Validation Master Plan for manufcatuing equipment and all utility systems used in the manufacturing of an API.
  
• Wrote IQ, OQ and PQ protocols on the following units: Walk-in storage freezer, refrigerators by Fisher Scientific, Revco and Marvel Industries, Glass Chemical Reactors, Separation columns, Glove boxes/ isolators, Plant nitrogen system, Ovens by Thelco and Precision Scientific, Plant refrigerated water systems, Plant vacuum systems, Filter dryers, and Purified water systems.
  

Validation Specialist/Project Supervisor, LXR Biotechnology, Alameda, CA.

• Wrote and executed IQ/OQ protocol for a walk-in refrigerator

Sr. Validation Specialist, Oread Labs (Contract Manufacturing Company for Solids and Semi Solids).

• Served as on staff validation specialist responsible for daily validation activities.
  
• Interfaced with various manufacturing departments to support their validation activities. Duites include working with solids, semi solids, and sterile fill areas.
  
• Developed and executed IQ/OQ/PQ validation protocols for the plant's formulation development and clinical manufacturing departments.
  
• Validation projects included the following units: Powder fillers by All-Fill, Metal Detectors, Lab Coat II tablet coaters by O'Hara Industries, Capsule check weighing units by Vericap 2100 and Mocon, Tablet presses by Novapress 61 and Manesty Beta 16, Mixers by Patterson Kelley (V-shape) and Gemco (double and Slant Cone), Capsule fillers by Bosch Capsule Filler and King Capsule Fillers, Capsule polishers by Key Industries, Fluid bed dryers/granulators by Niro Fielder, Milling units by Quadro Co-mill and Fitzpatrick, Roller compactors by Frued, Ovens by Hotpack and Revco, Lyophilizer, Clean rooms, Plant HVAC systems, Plant nitrogen and water systems.
  
• Packaging lines with the following assembly: Powder filler by All-Fill, Check weigher by Garvens, Capsule filler by King , Dust collector by Tori, Cap Orienter by Kaps-All, King Cottoner by King, Induction Sealer by Emerson Industries , Labeling unit by New Jersey Machine Labeler, Video Jet Printers, Sealer by Shanklin L-Bar

Validation Specialist, Shaklee Corporation, Hayward, CA.

• Wrote and executed IQ/OQ validation protocols for the following equipments: Incubators manufactured by Lab-Line Revco, Precision Scientific and Fisher Scientific, Environmental chambers used for stability studies, Tablet Coating units by Ohara Industries, Tablet Presses by Manesty and Stokes, Automatic Balance Systems by ABB, Check weighing units by Garvin, Capsule Filler by Zanasi, Capsule Polishers, Mixers by Littleford, Blenders, Fluid Bed Granulators by Glatt Industries.
  
• Assisted engineers in the development and executions of IQ/OQ/PQ protocols for the manufacturing pilot plant HVAC system.
  
• Conducted annual audits on equipments used for process development.
  

Validation Specialist, Alza Corporation, Hayward, CA.

• Wrote SOPs for the following equipments and utilities: Optical inspection and measuring instruments, Ovens, Tablet Coaters, Take-up Units, Solvent Tanks, Thermal Oxidizers, Lee Vessels with Lightning Mixers, Environmental Monitoring systems.
  
• Revised and reviewed SOPs for various equipment used in clinical and commercial manufacturing.
  

• Working Knowledge of FDA and international guidance documents
  
• Working Knowledge of FDA Regulations applicable to manufacturing or drugs, biotech products, and medical devices
  
• Knowledgeable of the following test instruments: Oscilloscopes, Multimeters, RCS, Climet Particle Counter, Draeger Tubes, Gastech Inc gas analyzer, Kaye Instruments Digi 4 plus utilizing the Validator and Validator 2000 Software
  

• 3 day seminar on CFR 21 Part 11 and on Computer Validation Life Cycle given by Baxter Hyland Immuno- 2000
  
• 3 day seminar on cGMP and Documentation Practices given by Baxter Hyland Immuno- 2001
  
• 2 day Seminar on the basics of thermal mapping given by Kaye Instruments
  
• 4 day Computer Systems Validation Training given by Terra Technologies - 1998
  
• cGMP Training - History of cGMP, Documentation Requirements, Dress Code Requirements, Labeling Requirements, Production and Process Control and Preventing Cross-Contamination, Environmental Monitoring Requirement, Logbooks, and Cleaning Requirements.
  
• 2 day Seminar Regulatory Compliance - The FDA Inspection (How to Successfully Prepare for, Manage and respond to an FDA Inspection)
  

• CBER Medical Device Training, December 2007
  
• Basic Drug School, March 2007
  
• 2 Week Aseptic Processing Training Program ( Principles and Practices in Aseptic Processing of Small Volume Parenterals) May 2005
  
• 2 Week Core Team Biologics Training, October 2004
  
• 1 Week Food and Drug Law 2/ Compliance Law, March 2005
  
• 1 Week Bioreactors/Fermentation/ Purification, March 2005
  
• 3 Days Quality and Risk, April 2005
  
• 3 Days Using Turbo EIR for Establishment Inspection, June 2006
  
• 3 Days Pharmaceutical Quality Assessments- A Science and Risk Based CMC Approach in the 21st Century, October 2005
  
• Food and Drug Law Prohibited Actions
  
• 1 Week A Step by Step Approach to Process Validation, August 2004
  Basics of Inspections
  
• 2 Week Basic Drug Law Course, September 2004
  
• 1 Week New Reviewers Workshop, June 2004
  
• 3 Day Drug Quality Systems-cGMP for a New Era- 2005, August 2005
  
• 1 Day FDA Jurisdictions/Evidence and Proof/ Inspectional Observations, February 2005