Recent Projects

Contract Manufacturing Organization of Sterile Injectables, Massachusetts

• EU Annex 1 Remediation project, to institute the various change controls, procedures, MBRs, protocols, etc to enable improved compliance to Annex 1 requirements

Large Sterile Drug Product Manufacturer, Midwest US

FDA Warning Letter Remediation

• Technical Writing
• Develop and/or revise production SOPs, batch records, forms and training records

• Event Investigations
• Investigate, write and closeout Root Cause Investigations and CAPAs
• Provided guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all investigations, corrective and preventive actions (CAPA), and CAPA effectiveness
• Worked with operations leadership and Quality Assurance to facilitate the consistent and disciplined execution of the investigation system ensuring the completeness and comprehensiveness of the investigations and CAPA

• Engineering
• Retrospective evaluations of Technical Specifications for critical equipment, facilities and utilities to support requalification project.

Large Pharmaceutical Manufacturer, Pennsylvania

Remediation project for FDA Consent Decree

• Third party Engineering/GMP oversight of $200MM rebuild of a pharmaceutical liquids manufacturing facility
• Consulted on the development of Critical Aspect Risk Assessments, VMP’s (Site, Cleaning, Process, Equipment/Facility/Utilities, Computer Systems, Lab), Qualification/Validation Protocols and Reports.
• Provided guidance and review on the complete rewrite of all site engineering maintenance, calibration and operating procedures and policies.

Mid-Size Rx Drug Product Manufacturer, New Jersey

Warning Letter Remediation – Warning Letter Lifted

• Cleaning Validation: preparation of Master Plan & matrix scheme. Drafted sampling plans and MAC calculations.
• Process Validation: PV program gap assessment and remediation
• Packaging Validation: Drafted Master Plan, Gap Assessment and Remediation

Mid-Size OTC Topical Drug Product Manufacturer, New York

• Remediation project for FDA inspectional observations.
• Drafted response to the FDA-483 inspection report. Attended meeting with company senior management at FDA field office to present the Corrective Action Plan.
• Implemented Corrective Action Plan, Product Assessments, Quality Systems Appraisals and Process Validations.

Large Rx Pharmaceutical Manufacturer, New Jersey

• Commissioning and Qualification of Equipment, facilities and Utilities related to the move of an entire stability facility and labs from one location to another (within state)

Mid-Size OTC Drug Product Manufacturer, New York

• Developed Cleaning Validation Master Plan, Cleaning Validation protocol master design
• Developed Process Validation Procedure and implementation, drafted Process Validation Protocols/Reports

Large Generic Drug Manufacturer, New Jersey

• Led the qualification of equipment, facilities and utilities related to two major manufacturing area additions.
• Qualifications included Water Systems, Fluid Bed Dryers, High Shear Mixer, V-Blenders, Mills, HVAC Systems and Production Suites. Produced Protocols, execution, reports.

Large Vaccine Manufacturer, Pennsylvania

• Leader of Commissioning, Qualification and Validation Project for the renovation of a vaccine manufacturing facility utilizing ISPE C&Q and ASTM E2500 methodologies.
• Authored Project Commissioning and Qualification Plan, Commissioning and Validation Project Plans, Commissioning Test Plans and other related project documentation.

Stem Cell Processing Facility, New York

• Commissioning and Qualification of a new facility and laboratories for the processing and testing of Umbilical Cord Blood into stem cells for use in Cancer Patients.
• The ISPE Commissioning and Qualification approach was utilized from the outset realizing time and dollar savings.
• Troubleshooting and repair of many of the systems. Coordinated major move of the LN2 units (full of product inventory) from Manhattan to Queens, working with NYPD and Riggers. Coordinated temperature testing, equipment qualification, etc.
• Timely project execution enabled company to have most profitable quarter in history.

Large Pharmaceutical Manufacturer, Pennsylvania

Liquid and solid dose pharmaceutical manufacturing

• Drafted over 40 equipment cleaning validation protocols for the various oral solids and liquids products manufactured by the site
• Gap Assessment and remediation on 18 HVAC units servicing the GMP manufacturing areas of the plant. Includes drafting of the protocol, identification of gaps in the qualifications, assessing impact of gaps and preparing remediation plan
• Performance Qualification protocol for the USP Purified Water plant which serves to produce the water used for the manufacturing operations at the site

Contract Manufacturer of Sterile Ophthalmics, Italy

• Successful remediation projects for company under FDA Warning Letter. Subsequent FDA audit was successful with only 3 minor observations
• Performed mock FDA audits and made recommended improvements

Large Sterile Injectable Manufacturer, Ohio

• End-to-End Sterility Failure Mode Effects Analysis (FMEA) of manufacturing process within the sterility boundary, from Compounding (microsphere formation), Sieving to Final Filling (13 FMEA Unit Operations). In an effort to reduce batch rejections of an extended release, auto injector product
• Drafted complete set of remediation plans for high RPNs and those high impact areas (using Pareto Analysis)

Contract Manufacturer, Transdermal Product, New York

PAI readiness activities at CMO for product owner. Assessment reports with corresponding remediation plans for:

• Equipment cleaning procedures and cleaning validations
• Environmental Monitoring Program
• Computerized System Validations

Medical Device Manufacturer, New York

• 2015: Performed internal audits per ISO 13485 of all 11 departments. Trained new QA Specialist to perform
• 2015: Provided interim Operations leadership while searching for full-time leader.
• 2012: Performed temperature mapping of 4 Warehouses for Summer and Winter seasons.

Large Contract Packaging House, Illinois

• On-site Validation and QA representative for the drug product owner at the contract packager during Packaging Validation and the product launch of Zyrtec (Cetirizine HCL), transitioning from Rx to OTC.

QC Analytical Lab Leader, startup oncology company with FDA fast track approval NJ

• Established Analytical Laboratory in support for launch of the first commercial product

Project Engineer, new mAb facility for startup oncology company with FDA fast track approval NJ

• Led the build out of two buildings – one aseptic production facility and a warehouse
• Managed budget, timeline and contractors

Sr. Director of Manufacturing Quality, large generic oral solids manufacturer, NC

• Leader of the Quality Engineering group tasked with manufacturing deviations and CAPA

Manager of Validation, CMO of Sterile Injectables, MA

• Lead the validation group during a facility expansion and loss of Validation leadership

Assistant Director of Quality Assurance, CMO of Sterile Injectables, MA

• Assist the Director of QA in management of deviations and CAPA

Sr. Microbiologist, CMO of Sterile Injectables, MA

• Support micro lab in the development of environmental trend reports and day-to-day micro lab activities

Director of Operations – Medical Device manufacturer

• Temporary leadership for the Operations department
• Staff assessment
• Schedule and workflow recommendations, training recommendations

Sterile Injectable Manufacturer, Missouri

• Manage SOP Optimization Project: Project includes assessment of current GMP work instructions and plan to optimize SOP content while ensuring clear, concise instructions for production operations
• Provide technical writing support for aseptic operations, including drafting new/revised SOPs, forms, training materials, and OJT skill assessment documents

International Academy of Compounding Pharmacists

• Developed and presented Webinar – “GMP’s for the Outsourcing Pharmacy”

Sterile Injectable Manufacturer, Ohio

• Training of Aseptic Operators in aseptic practices. Monitored/enforced aseptic practices in the sterile core

Sterile manufacturer of allergen extracts, New York

• Prepared and presented general GMP training for entire company staff

Outsourcing Compounding Pharmacies - Connecticut, North Carolina, Arkansas and Kansas

• Performed FDA-Style audit of facilities for compliance against cGMP’s and FDA Guide for Sterile Outsourcing Facilities
• Approved by the Virginia State Board of Pharmacy to perform these types of audits for outsourcers desiring to do business in the state

Outsourcing Compounding Pharmacy, New York

• Performed a Quality Management System Assessment against FDA cGMP Guidance for Outsourcing Facilities and draft USP General Chapter <797>. Developed a remediation plan outlining all activities to correct identified gaps
• Designed new Quality Management System. Drafted new contemporary, compliant corporate Policies and Procedures for entire compounding operation
• Drafted FDA correspondence - response to Warning Letter, Corrective Action Plan, Quarterly updates
• Represented company at meeting in local FDA office with FDA CDER presence – updated progress on quality improvement and described operations

Large National Pharmacy Chain
Various Sterile Compounding Pharmacy Organizations (503A and 503B), Nationwide

Company locations under FDA Warning Letter and/or possess 483 inspectional gaps

• Performed audit of facilities for cGMP compliance against FDA Guide for Sterile Outsourcing Facilities
• Evaluated compliance of sterile operations, facility design and quality systems
• Drafted remediation plans for recommended corrective actions against identified gaps

Large Sterile Compounding Pharmacy Corporation (503B), Midwest

• cGMP due diligence audit of two manufacturing sites for a private equity firm for potential acquisition