Dr. Jeffrey M. Singer
PharmaBasics, Inc.
P.O. Box 220497
Great Neck, NY 11021
Phone:
(917) 952-2506; (516) 466-4808
Fax:
(516) 466-4808
E-mail: pegasus013@yahoo.com
PharmaBasics, Inc
Compliance Solutions for the Pharmaceutical Industry
COMPANY DESCRIPTION
PharmaBasics, Inc. is a validation and CGMP consulting company, offering a range of validation and quality system services for your CGMP/GLP facility. PharmaBasics brings to you the experience, knowledge and expertise needed to effectively and efficiently execute your validation projects. Dedication to quality is paramount in all our activities and our personalized support ensures the success of outcome of your projects.
PharmaBasics provides to you:
- Extensive experience with current industry regulations and standards
- Qualified and experiences validation professionals
- Commitment to your satisfaction
- Competitive rates
PharmaBasics, Inc. = Value Added Business and Compliance Solutions
VALIDATION SERVICES
Validation is the core of pharmaceutical business reality in today's regulated environment. Our consultants are dedicated professionals who keep current with validation issues, standards, trends and regulations. The result is a superior level of consulting, writing and execution services that stand up to FDA and EU inspection.
PharmaBasics' range of services includes:
- Validation Project Management
- Validation Master Planning
- Utility and Equipment Specification Development
- Construction Qualification Project Management
- Facility and Utility Commissioning and Validation
- Preventive Maintenance Program Development
- Metrology Program Development
- Best Practices in Quality Management
- CGMP Compliance
- Good Documentation Practices
- Computerized System Validation / Part 11 Compliance
- Process Equipment Validation
- Process Validation
- Cleaning Validation
- Analytical Test Methods Validation
- Standard Operating Procedure (SOP) Preparation
- Stability Monitoring Program Development
- OOS Investigations
- Stability Chamber Selection and Qualification
- Revalidation
- Vendor Assessments and Audits
COMPUTERIZED SYSTEMS / VALIDATION SERVICES
Our consultants have extensive experience in the validation of integrated software and hardware systems. From process control, data acquisition, PLC- or PC-based our computer software consultants are able to verify and document that your system is CGMP compliant.
PharmaBasics' CSV capabilities include the following:
- Software Quality Assurance Program Development and Audits
- System Requirements Document Development
- Functional Specifications Development
- Traceability Matrix Document Development
- Qualification Protocol Preparation and Execution
- Technical Writing and SDLC Document Preparation
LABORATORY SERVICES
Expert consultants in the fields of laboratory auditing and procedure implementation can assist in developing methods and quality control procedures, on site.
- Analytical Method Development and Validation
- Analytical Equipment and Laboratory Computer Systems Qualification
- GxP Auditing
- Laboratory Design, Implementation, Commissioning and Equipment Qualification
- Raw Material Qualification
- Standard Operating Procedures (SOPs) Preparation
REGULATORY COMPLIANCE
PharmaBasics' Quality Assurance and Regulatory Affairs professionals can bring additional expertise and resources to any company. PharmaBasics' professionals can assess existing quality systems for established firms or design new systems for newer firms to assure that your development projects have an easy transition into clinical trials in order to achieve commercial success.
Our staff professionals can provide:
- Common Technical Document (CTD) Dossier Preparation for NDA/ANDA/SNADA
- GAP analysis for compliance with Regulatory CTD documentation requirements
- GAP analysis and remediation for compliance with 21 CFR Part 11 (Electronic Records and Signatures regulation), GLP and CGMP requirements
- Vendor Qualification and inspection of suppliers, contract manufacturing, testing laboratories, equipment vendors and software developers
- Training and education in CGMP, GLP and 21 CFR Part 11 regulations
- SOPs for Quality Systems, Documentation and Software Quality Assurance
- Vendor Assessments / Audits
- CAPA (Corrective Actions and Preventative Actions) Systems
- Agency Inspection Deficiency Corrective Actions
- Quality Assurance Systems Analysis
- Technical Writing, Document Preparation and Review
WHO WE ARE
PharmaBasics' validation professionals have extensive hands-on experience, over many years, with utility systems and equipment used in the pharmaceutical industry. PBI can offer unique solutions to the common staffing, experience, schedule and budget challenges faced in today's market place. For new installations and facilities, PharmaBasics' professionals can perform validation activities concurrent with construction and commissioning, enabling production activities to commence much sooner. For newer companies or departments, we can assist you in establishing protocol formats and content in order to meet FDA expectations. For established companies, we can easily adapt to your established formats. Our combination of flexibility and experience is designed to meet your needs.
PRINCIPAL: Jeffrey M. Singer, Ph.D.
A senior R&D professional with Ph.D. in Organic Chemistry and over 25 years technical, managerial and scientific experience, gained with major pharmaceutical, multi-national companies and start-up, development stage biotech companies. Over 20 years in the pharmaceutical industry, including parenterals, liquids, solids and semi-solids.
EDUCATION:
- Ph.D., Organic Chemistry, Polytechnic University, Brooklyn, NY; Thesis Advisor: Mark M. Green
- M.A., Chemistry, Queens College, Flushing, NY
- M.S., Geochemistry, Rensselaer Polytechnic Institute, Troy, NY
- B.S., Chemistry, Queens College, Flushing, NY
BUSINESS STRENGTHS:
Considered "Scientifically Nimble" by virtue of the following factors:
- Broad perspective due to diverse technical background.
- Collaborative in spirit and entrepreneurial by nature.
- Offer a holistic approach to problem solving: able to integrate separate pieces of information in order to formulate a game plan [dissect/work through/arrive at solution].
- Ability to gather hard-to-find information quickly.
- Attention to detail; excellent analytical skills.
- Excel at hard-to-tackle projects.
- Excellent written and oral communications skills; excel at technical writing and preparing technical compliance documents, SOP's, validation reports, CMC stability summary reports
- Mutual-Benefit Leadership skills: foster a team-oriented work environment based on mutual cooperation for mutual benefit; look for Win-Win partnering outcomes.
- Excellent organizational skills; believe in delegation of tasks to best-suited individuals.
- Computer literate; familiar with development and implementation of Laboratory Information Management Systems and 21 CFR Part 11 Compliance issues.
- Proficient in Analytical Equipment and Laboratory Computer Systems Qualification.
EXECUTIVE SUMMARY
A senior R&D professional with a Ph.D. in Organic Chemistry and 25 years technical, managerial, business process and scientific experience, gained with major pharmaceutical, multi-national companies and start-up, development stage biotech companies. Over 20 years in the pharmaceutical industry, including parenterals, liquids, solids and semi-solids. An innovative problem-solver who has overseen the development of robotic methods for the analysis of small molecules (Coumadin®), engineered the technology transfer of release and cleaning validation methods for the production of an Alzheimer's drug, generic OTC and sterile products, troubleshooting production problems for pain management drugs (Percodan®, Naloxone®, Narcan®, Numorphan® and Naltrexone®) and the development of new analytical methodologies for flavorants (Vanillin). Expertise in GxPs, GMP audits (API), analytical methods validation, technology transfer, computer validation, 21CFR Part 11 compliance, SOP preparation and CTD Dossier preparation for NDA/ANDA's and Supplements.
- Excellent written and oral communications skills; excel at technical writing and preparing technical compliance documents, SOP's, validation reports, CMC stability summary reports and CTD Modules 2,3
- Mutual-Benefit Leadership skills: foster a team-oriented work environment based on mutual cooperation for mutual benefit; look for Win-Win partnering outcomes.
- Strong analytical and problem solving skills with an ability to get to a root cause
- Excellent organizational and Project Management skills (Kepner-Tregoe Project Management training)
- Computer literate; familiar with software development life cycle (SDLC) and computer/software validation
TECHNICAL EXPERTISE:
- GMP Audits: Certified API Auditor for Q7A (SGS Certification)
- CTD Dossier Preparation
- Analytical Equipment Validation: IQ, OQ, PQ
- Stability-Indicating Method Development / Validation / Transfer
- Part 11 Compliance and GAP Analysis
- Best Practices in Quality Management: Quality Systems and CGMPs
- Validation Master Plan Development
- Stability Protocol Development
- LIMS and Laboratory Data Acquisition Computer Systems
- Computerized Systems Validation Deliverables (UFRS, CRS, FAT, SAT, IQ/OQ/PQ, RTM, VSR)
- Proficient in Microsoft Office software, MS Project, MS Visio, Adobe Acrobat
- Software Applications worked with: Documentum, Trackwise, ISOtrain, ERP/MRP, EDMS, Maximo
PROFESSIONAL EXPERIENCE:
PHARMABASICS, INC., New York ; 2003 - Present
Senior Consultant
- Completed product assessments of 12 ANDA filings: determined whether the product was manufactured and tested in conformity with CMC controls and FDA-approved applications; and whether analytical methods for in-process controls, finished product testing and stability monitoring were reliable and accurate
- Created CTD Module 3 Dossiers for registering OTC products in domestic and new overseas markets
- Prepared CTD GAP Analyses for needed materials for drug substances, products and excipients
- Provided QA/QC for clinical documentation support at a biopharmaceutical company for an NDA registration package: revised and edited PK/PD reports, clinical study reports, CTD Modules 2 an 5
- Authored 100% Effectiveness Recall Script for a repackaging operation of a firm that serves long-term care facilities; drafted an SOP for Destruction of Controlled Substances incorporating DEA Form 41
- Authored stability system SOPs for a clinical supplies repackaging facility
- Audited LC/MS method validations at a clinical trials CRO in support of clinical trials testing; provided GAP analyses comparing methods validation status against current ICH criteria
- Investigated risk assessments and documented findings in response to FDA Warning Letters
- Prepared, executed and/or conducted reviews of CSV deliverables including but not limited to compliance assessments, corrective action plans, CSV and SLC documentation (validation plans, user/functional requirements, configuration specifications, protocols (IQ/OQ/PQ, UAT, traceability matrices, etc.), test scripts, test summary logs, and validation summary reports) in support of Computer System Validation
- Conducted GMP audits for Operational Compliance and developed responses to FDA Compliance Problems, Notices of Observations, Warning Letters and Consent Decrees
- Performed independent assessment of the business process, roles, responsibilities and functions of Quality Unit operations for Product Development R&D groups for conformance to CGMPs
- Reviewed Stability Programs, protocols, studies and supporting documentation for data integrity, accuracy and completeness; assessed handling Out-Of-Specification results, Deviations and CAPAs
- Reviewed and executed test scripts for the commissioning of a variety of manufacturing equipment and PLC devices, including labelers
- Reviewed CAPA investigations for laboratory and manufacturing operations for outstanding issues
- Developed documentation as required for assigned projects (SOPs, guidelines, summaries, etc.)
PHARMABASICS, INC., New York ; 2002 - 2003
Computer Validation Specialist - Consent Decree Consultant
- Reviewed and certified computer performance qualification documents for enterprise-wide applications, spreadsheets, operating systems, user interfaces, etc., under the terms specified in the Consent Decree document and compliance with CGMP's and 21 CFR Part 11
- Requested corrections to validation documentation, as required
- Audited unexecuted protocols and executed computer system validation studies for applications such as (but not limited to) SAP, Documentum, TrackWise, CMMS, EDMS, WMS, ISOtrain, etc., for conformance to predetermined acceptance criteria and compliance with CGMP's and 21 CFR Part 11
- Assured all documentation, such as Change Control, SOP's, training records, etc., conformed with the terms specified in the Consent Decree and compliance with CGMP's
- Authored reports summarizing any deficiencies of protocols and/or study results for subsequent FDA review
- Issued approval certificates for subsequent protocol execution and/or study results following resolution of all issues and compliance with CGMP's and 21 CFR Part 11
- Trained three (3) additional consultants to support computer validation efforts and successfully met the Consent Decree commitment project timelines
- Subject matter expert on computer system validation / Part 11 questions and issues
- Reviewed current SOPs and work instructions for predicate rule compliance, security requirements, disaster recovery, and data retention plans
EMISPHERE TECHNOLOGIES, INC., Tarrytown, New York ; 2000 - 2002
Associate Director, Quality Support Services
- Managed the operation of a quality control unit including the GMP Laboratory Documentation Control and Stability, with supervision of technical personnel supporting new product research and development
- Prepared department budget of $3,000,000 for staffing and $500,000 for capital equipment
- Designed new analytical testing laboratories in conjunction with facilities expansion
- Prepared commissioning and validation documentation for major laboratory equipment (e.g., GC, HPLC)
- Reviewed and approved all IQ/OQ/PQ validation protocols and executed protocols for CGMP compliance
- Reviewed all sponsor-developed clinical trial protocols for new carrier/drug combinations
- Technical Writing included authoring of compliance documents, stability reports for CMC sections, SOP's specification documents & certificates of analysis ( COA's ), stability portions of the CMC section for NDA filings, Out of Specification ( OOS ) investigation reports, GLP toxicology sample analysis summary reports and reporting of clinical pharmacokinetic data; implemented change control procedures
- Authored primary ICH harmonized stability protocols for transfer to contract research organizations and reviewed all data received for product quality assurance
- Authored Change Control SOP and established company Change Control Review Board
- Successfully completed computer validation report for laboratory Turbochrom Workstation
- Contributed to writing Requirements and Functional Specifications documents in compliance with 21 CFR Part 11 for Turbochrom Client Server as a member of corporate Turbochrom Validation Team
- Interacted with FDA during routine inspection and eliminated potential 483 observations
- Authored Quality function SOPs; conducted training on new and revised SOPs
- Member of corporate Global Disaster Recovery Team; contributed to development and implementation of company disaster recovery plan; Member of Process and Equipment Validation Committee
G&W LABORATORIES, INC., South Plainfield, New Jersey ; 1997 - 2000
Manager, Analytical Research and Methods Development
- Managed the operation of an R&D lab with 8 technical personnel for new semi-solid generic OTC product development in support of the overall business process
- Prepared Cleaning Validation Master Plan for all products, to adequately address Warning Letter deficiencies which resulted in product withdrawals
- Team Leader of Cleaning Validation Project responsible for successfully coordinating and tracking all cleaning validation testing activities to ensure compliance
- Prepared 13 product cleaning validation protocols, managed successful execution and authored all reports within 6 months without any FDA 483 observations upon re-inspection
- Investigated vendors and coordinated demonstrations of new laboratory chromatography data systems in order to comply with up-coming 21 CFR Part 11 requirements
- Reviewed all in-coming method validation reports from contract research organizations ( CROs ) for accuracy, completeness and compliance with USP and FDA method validation guidelines
- Successfully coordinated transfer of all new methods to Quality Control from developing groups; prepared technology transfer reports certifying acceptable methods transfers
CLAY-PARK LABS, INC., Bronx, New York ; 1995 - 1997
Manager, Contract Product Development (1996-97)
- Managed the business process of project planning and coordination for new semi-solid product development with contract manufacturing and research firms and ensured compliance with QC criteria, SOPs, GMPs and contractual guidelines
- Managed contract-developed business process product Life Cycle, from initial patent reviews for development potential to confidentiality agreements to technology transfer and clinical studies through regulatory filings
- Directed the successful and on-time start-up and operation of a new R&D lab with 6 technical personnel supporting semi-solid generic, OTC and cosmetic new product development
- Negotiated with vendors for cost effective purchase of supplies and major equipment (GCs, HPLCs, computers, printers) approved laboratory design specs, wrote job descriptions recruited laboratory staff
- Successfully developed company-wide Technology Transfer strategy for a 33% time reduction
- Authored 25+ SOPs and conducted staff training to rectify all laboratory FDA 483 compliance observations
- Conducted staff training on CGMPs and new / revised SOPs
- Authored and published new, validated HPLC methods for Nitrofurazone products in USP PF (5/97)
- Successfully completed 3 product transfers from international parent company in Israel to CPL
- Designed and successfully implemented an Excel spreadsheet generating QC Stability Test and Spec Protocols to meet FDA compliance initiatives
DUPONT MERCK PHARMACEUTICAL CO., MFG. DIV., Garden City, New York ; 1990 - 1994
Principal Scientist, Analytical Technology (1993-94), Manager, Analytical Technical Support (1990-93)
- Provided direct analytical troubleshooting expertise supporting products and processes for parenteral, oral liquid and solid dosage forms; reviewed and edited stability and analytical sections of CMC for NDA filings
- Provided direct technical support to proprietary development projects, such as robotics, Warfarin API, Coumadin analytical/process validation and product transfers
- Directed the startup and operation of a new global analytical technical support lab with 19 Chemists, and a $1,250,000 annual budget; designed new analytical lab facilities to support technical activities
- Received "Accomplishment Award" for preventing $5,000,000 monthly revenue loss of major product line
- Successfully coordinated technology transfers for Technical Operations between QC and R&D to Italy, Ireland and Puerto Rico; reviewed and approved all method transfer documents
- Project Leader for Site LIMS Implementation; contributed to writing requirements and specifications documents for implementation of Fisons VG Multichrom LIMS
- Served on Corporate Analytical Steering Committee; Corporate Stability/LIMS Implementation Team
PALL CORPORATION, Glen Cove, New York ; 1989 - 1990
Laboratory Manager, Scientific and Lab Services
- Supervised 15 Analysts performing wet chemical and instrumental testing of filtration products supporting R&D, manufacturing, sales and marketing; major analytical equipment purchases (HPLC and FTIR)
- Authored Laboratory SOP Manual for all lab test methods and procedures
PEPSICO, INC., Valhalla, New York ; 1987 - 1989
Senior Chemist, Concentrate Operations
- Responsible for analytical instrumentation purchases and $500,000 capital analytical instrument budget
- Successfully coordinated R&D, validation, documentation and specifications of new test methods
- Successfully developed and conducted Analytical Round Robin Auditing Program for 11 global plants
LEDERLE LABS, Div., AMERICAN CYANAMID, Pearl River, New York ; 1986 - 1987
Analytical Development Chemist
- Performed analytical method validations for new proprietary and standard products established testing protocols for stability monitoring; Member of Company Annual Product Review Committee
REVLON HEALTH CARE, Tuckahoe, New York ; 1981- 1986
Senior Chemist/Laboratory Supervisor (1982-86); Assoc. Senior Chemist (1981-82)
- Supervised 2 Research Assistants performing USP test methods on new products and raw materials
- Successfully Managed Company Reference Standards Program; Member of Radiation Safety Committee
CHEMTECH CONSULTING GROUP, INC., New York, New York ; 1980 - 1981
Group Leader
- Supervised 2-3 analysts performing EPA test methods by GC on water and wastewater samples for pesticides, herbicides, PCBs and EPA Priority Pollutants for environmental projects; prepared reports for clients
- Major purchases of new equipment (GCs, Headspace Analyzers, Hall Detector, Class A Fume Hoods)
EQUITABLE ENVIRONMENTAL HEALTH, INC., Woodbury, NY ; 1979 - 1980
Analytical Chemist
- Performed EPA, NIOSH, DoA test methods on water, air, soil, and wastewater samples for pesticides, herbicides, PCBs, EPA Priority Pollutants by GC and GC/MS, for TSCA, RCRA and OSHA projects
- Developed methods for GC/MS PCB analysis and Headspace analysis of airborne contaminants
- Prepared sections of Company Quality Control Manual relating to organic pollutant analysis
