Daniel Meshnick Associates LLC, NJ 7/2015 to present
Senior Consultant
5/2016 to 8/2016 – validation and compliance consultant for a major EU manufacturer of an anti-infective API.
2/2016 to 5/2016 – Major project to remediate the compliance deficiencies for a Canadian nutraceutical/OTC and homeopathic manufacturer for Health Canada.
7/15 to 1/2016 – Major projects to:
Develop a validation program for a live bacillus vaccine for a top 5 pharmaceutical company including the GAP assessment, review of legacy manufacturing data, develop and perform process risk assessment and develop and approve SOP’s for the validation program and the document control systems.
The Quantic Group, Ltd., Livingston, NJ, 2009 to 7/2015
Consultant
Subject Matter Expert for the sanitizing and sterilization for the remediation of cRABs and isolators for a major Indian firm under FDA consent decree. Reviewed and established facility cleaning and disinfectant procedures for the Class A and B areas in the manufacturing areas.
Reviewed and established engineering controls for the aseptic transfer of product to and from the lyophilizers in a Class B area.
Consent Decree Verifier for a major consumer goods manufacturer under FDA Consent Decree. Specific areas of expertise includes Facilities and Utilities, Cleaning and Sanitization, Calibrations, Engineering Processes and Process Validations. Reviewed and edited all relevant Validation Master Plans, SOP’s and completed protocols and reports for Corporate and three manufacturing sites. Responsible for establishing Risk Assessment policies based on industry standards and practices. Performed FMEA and Ishikawa assessments for processes, facilities and utilities for major site renovations.
Managed the Quality Engineering and Validation function for a major remediation effort for Generic Solids and Liquid dosage facility under a major warning letter. Managed the remediation of the facility and process validation efforts. Responsible for the remediation and validation efforts for Purified Water, Potable Water, Clean Compressed gas generation and distribution systems. Managed the Quality monitoring of the quarantine and sanitizing of a facility having a mold contamination problem.
Validation team lead for the facilities, equipment and process validation remediation efforts for a Solid Dosage facility that prevented a possible consent decree. Coordinated the site contract validation team along with a team of outside contractors performing the planning, executing and reporting of engineering, and construction projects in order to improve the compliance profile of the site. This included the review of all protocols and final validation reports.
CODA Corporation, 2008 to 2009
Senior Validation Consultant
As the Sterilization SME, performed sterilization (SIP), cleaning (CIP) and process improvement for a major vaccine manufacturer in response to warning letter observations. Wrote protocols for the execution of cleaning validation studies for an aseptically produced bulk vaccine product. Involved with automated (Delta V) cleaning and robotic manufacturing processes. Performed CAPA investigations, writing and approving Validation and Development protocols, training and mentoring junior and mid-level engineers. Performed risk assessments and Root Cause analyses for CIP and SIP systems. Responsible for process improvements and validation assessments.
Acambis Inc., 2006-2008
Validation Manager
Managed the team for bringing an aseptic vaccine manufacturing and lyophilization facility on line, using state-of-the art aseptic isolators and RABS technology. Developed all of the protocols used for the validation of clean utilities, facilities and sterilization systems. Performed GAP assessments and developed CAPA plans for the remediation of compliance issues. Key member of the Government interface team for BLA licensing. Responsible for over $2 million in validation budgets.
AAC Consulting Group/Kendle International, 1999 to 2006
Senior Quality Consultant
Managed multiple quality and validation projects, providing both strategic and tactical planning for various major pharmaceutical manufacturers. These projects have included vaccine projects, lyophilization projects for human recombinant proteins and for veterinary drugs. Hands on troubleshooting projects involving both parenteral and solid dosage forms.
Have performed validation and quality audits all across the US, Europe and Pacific Rim venues. These include companies such as Akzo/Nobel, FMC Corporation, Wyeth, the United States Department of Defense, Abbott Labs, Schering Plough, Pfizer Corporation, LG BioPharma, Alcoa Medical and many other smaller companies. Below are samples of some of these projects:
- Validation Management for the Part 11 Compliance activities for a major computer development project for a department of the National Institute of Health (NIAIDS).
- Personnel training (GMP and Validations) for a bulk chemical manufacturer entering the veterinary market (Chr. Hansen).
- Managed the facilities and process engineering review for a major Indian API manufacturer (Atul, Ltd.).
- Managed the quality systems development for aseptic manufacturing processes. Redesigned lyophilization procedures for a major Korean biopharmaceutical manufacturer (LG BioPharma).
- Perform facility and manufacturing process design consultation for Vera Labs, Caraco and Glenmark Pharma. Assisted in developing batch manufacturing records and internal manufacturing SOP’s.
- Performed GMP training for operational personnel. Performed supplier auditing for a Fortune 100 Pharmaceutical Manufacturer (Pfizer, Groton).
- Performed the final review for the PAI validation batches for a major Pharmaceutical manufacturer (Amgen).
- Performed process validation audits in support of a mock PAI inspection for a major drug manufacturer (EISAI).
- Performed auditing and regulatory consulting for a manufacturer of pharmaceutical excipients (FMC Inc.).
- Performed facility design consultation for a solid dosage manufacturer (PenWest).
- Performed quality, validation and equipment engineering consultation for a “virtual” company developing a unique drug delivery system (Adolor, Corp.)
- Performed a comprehensive validation, quality systems and operational audit of a Fortune 100 Pharmaceutical Manufacturer (Schering Plough).
- Performed extended process and facilities engineering work for a critical vaccine supplier to the US Government (BioPort).
- Developed the cleaning and validation procedures for major cosmetic-pharmaceutical manufacturers (Kiehl’s and L’Oreal).
- Performed master plan review for a major cosmetics manufacturer (Avon).
- Performed mock PAI inspections and validation consultations for major API manufacturer (Chattem Chemical).
- Perform manufacturing, quality and validation consulting for veterinary manufacturing company (Hartz Mountain).
- Performed process optimization and PAI auditing for an HIV diagnostic device manufacturer (Orasure).
Marsam Pharmaceuticals, 1998 to 1999
Manager
Manager for facilities and process validations. The goal was for the improving of compliance in the area of equipment and facilities validation, as well as product/process validations. Responsibilities included master planning, staff recruitment and training. This also included development of a site validation policy and its implementation, and for the scheduling and budgeting of all validation activities. Managed eight validation engineers and was responsible for the facility metrology program (two metrologists).
Foster Wheeler USA, 1994 to 1998
Quality Manager
At Foster Wheeler, developed the cGMP compliance programs for all FW design projects in the pharmaceutical market. Performed manufacturing design reviews and regulatory consulting for clients and for Pacific Rim Corporate Divisions. Performed manpower estimating, project management and control, SOP development, GMP and quality systems training for the Pharmaceuticals and Fine Chemical Group. Involved with many projects including: process auditing for several EMEA clients; training for Japanese clients in validation and quality systems: these included IHI Heavy Industries and Kaneka; project planning for the construction and validation of $150 MM penicillin intermediates plant in South Africa; managing the engineering and validation of a bio-discovery/clinical manufacturing facility for Wyeth. Managed the validation for a GMP renovation of a solid dosage manufacturing facility for Wyeth; provided engineering consultation for an clinical aseptic manufacturing and research facility for Pfizer; and managed the validation of a $80 MM Interferon facility for Hoffmann-LaRoche
Akzo/Nobel - Organon Inc., 1987 to 1994
Manager, Process Validations
Quality Assurance/Tech Support Group: Managed all facilities, utilities and process validation activities. Interfaced will manufacturing, engineering and quality departments, providing critical input on process and GMP activities. These included establishing plans and policies for the automated/computer systems validations, equipment/utilities qualifications, process validations and packaging validations. While at Organon, managed the validation of five major products (including lyophilized processes), with total market values of over $300 million (1990 dollars).
Responsible for validation documentation; wrote, managed, reviewed and/or approved all validation protocols and reports. Performed process, GMP and quality system reviews of in-house (EU) and contract vendor manufacturing facilities.
Duties included the overall quality management of the department, specifically working with technology transfers for NDA products, cleaning procedures and validations, management of the calibration/Metrology department for all production equipment, Change Control Management for all process equipment, and the management of all re-validation activities. As part of these responsibilities, was involved in the OOS investigations process and CAPA activities for the company.
Among the projects that were managed included the design and construction of three new aseptic manufacturing facilities (HVAC building management), the installation and validation of lyophilizer systems, trained engineering teams for moist heat and dry heat sterilization processes; automated clean-in-place (CIP) and sterilize-in-place (SIP) systems; validation of WFI loops, a clean steam system, nitrogen NF distribution system. Validated the process and SIP for the prototype BD Hypak pre-filled syringe filler.
Product PAI’s: lyophilized Norcuron for injection (vecuronium bromide); lyophilized Arduan for injection (pipecuronium bromide); Zemuron for injection (rocuronium bromide); Desogen tablets (desogestrel, ethinyl estradiol); lyophilized Pregnyl for injection (chorionic gonadotropins); and lyophilized Humegon for injection (menotropins, LH & FSH).
Performed the technology transfer for clinical manufacture and process scale-up and manufacture of all new products. This involvement included reviews of CMC documentation sections of NDA filings, batch procedures, and site DMFs.
Direct reports included up to eight engineers and two staff metrologists.
Ben Venue Laboratories, 1983 to 1987
Validation Specialist, Quality Assurance Dept.
Responsibilities included HVAC and facilities engineering for the aseptic manufacturing core, sterilization and depyrogenation engineering studies; dry heat, steam and ethylene oxide (EtO) sterilizations; aseptic processing media fills; facility monitoring, aerosol particulate monitoring; design, installation, process, and operational qualifications. I wrote and executed validation protocols, analyzed data and wrote final validation reports; participated in the engineering, construction and certification of manufacturing clean rooms, HVAC, and HEPA filtration systems, managed DOP and air velocity certifications. Accomplishments include an automated non-viable particulate monitoring system, facility environmental monitoring; developed Quality Assurance procedures, manufacturing SOPs; lyophilizer validations including their controls and instrumentation; was a member of the plant metrology staff responsible for all instrument calibrations; qualified four lyophilizers, four aseptic manufacturing suites, and the plant automated WFI distribution loop.
Dehydro Tech Corporation
Process Development Technician
Performed new plant start-up, process development and pilot plant operations; multiple effect evaporator systems, vacuum drying and solvent extraction for industrial processing. Worked with the following clients: Adolph Coors, Inc.; Orange County, CA, Cadbury, ITT Raynier, Nestlè, Friendship Dairies, Pabst Breweries
Education
Bachelor’s Degree; Behavior Sciences, 6/78, Montclair State College, Montclair, NJ
Continuing Education Courses
cGLP and cGCP auditing, Risk Assessments, Control System Validations, cGCP Auditing, Master Planning and Personnel Management; through ISPE, PDA, PhRMA, and PHARMANET.
Professional Affiliations
- Parenteral Drug Association (PDA)
- American Society of Quality Control (ASQ)
- International Society of for Pharmaceutical Engineering (ISPE)
- Regulatory Affairs Professional Society (RAPS)
- Guest Lecturer for the Institute for Validation Technology (IVT)
- Guest Lecturer with Mr. John Lee on Automated Systems Validation for PHARMANET
- Involved in the writing of the ISPE BaseLine document on pharmaceutical water systems, sections on water for injection, pure steam systems and specifically on control systems for pharmaceutical water systems.
- Member of the PDA Task Force Committee on Automated Systems Auditing and Qualification.