Pharmaceutical Manufacturing and Regulatory Compliance Expert

Expertise

• Global market place creation and support; implementing systems, increase efficiency and sustain regulatory compliance in the pharmaceutical industries.
• In-depth knowledge and interpretation of regulatory requirements as applied to quality systems, cGMP, Good Laboratory Practices, laboratory equipment expertise.
• Vendor assurance programs, stability programs, validation (equipment, process, and analytical), manufacturing/ and laboratory operations.
• Commercial production and launch of pharmaceutical products fulfilling expectations by; ICH (International Conference on Harmonization) and FDA (Federal Drug Administration) relating to product.
• Accomplished leader with a proven track record to build, coach, mentor and motivate employees.
• Developed raw material methods, and improved analytical methods for existing medical devices.
• Performed analysis for enzymes, immunology, hematology, and chemistry technologies utilized for stability studies, research and development methodologies, scale-ups, and customer complaints. Establish specifications for products.
• Developed and validated ion-selective membranes, whole blood separator, chemistry for glucometer, lyophilized chemistries on various media.
• Responsible for technology development through engineering prototypes, to bring the product through pre-production stage for medical devices.
• FDA liaison to host PAI, GMP, For Cause Audits, and submission of Field Alert Reports.

Regulatory filing strategies for:

• Investigational New Drug, New Drug and Abbreviated New Drug Applications-IND/NDA/ ANDA applications.
• Drug Master File-DMF application.
• Corrective and Preventive Action -CAPA.
• Good Manufacturing Practice, Good Laboratory Practice-GMP/GLP.
• The United States Pharmacopeia and The National Formulary-USP/NF.
• Center for Drug Evaluation and for Biologics Evaluation and Research-CDER/CBER.
• Drug Enforcement Administration - DEA.
• Generally Recognized As Safe - GRAS.
• Quality by Design - QbD.

Experience

Independent Consultant, 2001 - 2014

• Projects and assignments for quality systems, product and process introduction, laboratory operations (Quality Control, QC, Research and Development, R&D), regulatory disciplines, remediation of systems, certification and consent decrees.

Projects

Novartis

• Created retrospective product assessment reports Candidate Physical Ability Test, (CPAT) for process validation, batch record review, filed artwork-labeling, analytical method validation assessment and trending reports for approved NDA and ANDA products.
• Compare filed Chemistry, Manufacturing, and Controls (CMC) commitments to the site programs in use.
• Assessed product investigations and OOS LIR's Out of Specification-Laboratory Investigation Reports for trending reports. Assessed the customer complaint system, gap assessment and provided audit reports of gaps and observations.
• Prepared FDA readiness slides for complaints, training, investigations, and APRs for the Sandoz Wilson, North Carolina plant.
• External Supply Operation (ESO) - Interim controls for investigations, change control, process (API, solid oral dose, transdermal devices), cleaning, packaging and analytical validation.
• Created training material and trained ESO personal for process validation, packaging validation, method validation, and cleaning validation. Assigned and created complaint quarterly trending reports.

Schering Plough

• Global clinical assignment to conduct investigations and publish investigation/interim reports for the Global Pharm-Sci Quality division Global Clinical Complaint department.
• Clinical complaints for devices, solid dosage forms, and sterile products.
• Created metrics and excel spreadsheet presentations for clinical complaint investigations to perform trend analysis to report to the Global Quality Council.
• Global clinical assignment to review batch records, product labeling, analytical data, investigation reports of clinical trial batches for the Pharm-Sci Quality division. Provide disposition of the clinical batch for clinical trial distribution at sites international and domestic.
• Created metrics and excel spreadsheets for Pharm-Sci Quality division regarding clinical quality activities and trend analysis.
• Support standard preparations, facilitate workshops, conduct benchmarking of best industry practices for the preparation and implementation of Level II SOPs.
• Consent decree certification team for SP's consent decree. Active member as the Third Party Product certification review of process validation for solid dose forms, devices, API's, creams, ointments and sterile products at four manufacturing sites.
• Ensure compliance with current GMP/ICH regulations during the certification process. Create checklists, reports and certificates of compliance for consent decree certification activities.

Sun Pharmaceutical

• QC Laboratory audit assignment involving a gap analysis to ensure operational compliance.
• Review the laboratory LIMS system to ensure current GMP and ICH requirements. Submitted audit report of observations and recommendations to improve compliance.

Mayne Pharma

• Global quality assurance assignment to monitor stability program, manage CRO's, and create several programs during a transition of a company merger.
• Remediate the client's stability program to current GMP and ICH requirements. Created procedures for shipping product with temp tales from the CRO's to the contract laboratories.
• Create database for the global vendor assurance program and global quality agreements. Created SOPs for the stability program, vendor assurance program and CAPA. Perform gap analysis for Global QA operations to meet current FDA and ICH guidelines.

Glaxo Smith Kline

• Certify Out-of-Specification (OOS) and nonconformance investigations to ensure current GMP compliance.
• Certify, review and audit of manufacturing batch records for compliance with current cGMP regulations and internal SOPs for solid dosage manufacturing processes for commercial distribution in domestic and international markets.
• Certification of manufacturing processes included granulation, compression, coating, solution preparation, and packaging, as well as analytical laboratory data.

Celgene

• Assignment to train laboratory personnel for instrumentation operation, which include creating training materials, mentored QC Supervisors and Chemists for laboratory operations, OOS and non-conformance investigations and data interpretation.
• Composed laboratory investigation reports for QC, commercial and clinical QA departments.
• Managed investigations and created a system for OOS and non-conformance investigation process and SOP.

Guardian Drug Company

• Conduct GMP audit of the facility and recommend remediation efforts. Created responses for client's FDA Warning letter.
• Recommended several system improvements and new systems such as CAPA to comply with current FDA and ICH regulations.

Tris Pharma

• Provide regulatory guidance and created documents for FDA NDA regulatory submissions. Train regulatory personnel the process for U.S. regulatory submissions.

Axiom Pharmaceutical

• Assignment to create analytical method validation protocols and reports for solid dosage forms. Trained QC senior chemist's to execute the method validation.
• Reviewed the analytical method validation data and created the validation reports. Troubleshoot analytical methods and instrumentation.

Employment

Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY, 2007 - 2010

Corporate Director of Quality Compliance

• Taro is a global pharmaceutical company with manufacturing operations in Canada, and Israel.
• Manufacture prescription and over the counter topical semi-solids creams, ointments, lotions, oral liquids and solid dosage forms which are imported and distributed to the U.S. market.
• Managed the corporate and global quality system to align with regulatory standards and regulations.
• Develop processes to build quality into products by providing global leadership with research and development, regulatory affairs, engineering and operations.
• Develop corporate policy standards. Perform gap analyses to remediate global quality systems.
• Implemented remediation to complex quality issues to resolve compliance trends and issues.
• Corporate representative for FDA inspections, FDA NDA field alert reporting, product recalls, and market withdrawals. Manage consultants.
• Remediate the quality system and manufacturing operation. Troubleshoot analytical and operation technical issues. Review and approve documents including SOPs, investigation and deviation reports, validation protocols/reports, compliance reports, CAPA and change controls.
• Created a quality plan to remediate quality systems for a warning letter at the Canadian manufacturing site. Member of the quality council.
• Created quality agreements for third party manufacturers, audit facilities and reviewed investigations.
• Oversight for the U.S. Consumer Complaint group ensuring thorough investigation reports completed in a timely manner by the appropriate manufacturing site or contractor.
• Interim Control for manufacturing investigations, customer complaint investigations, and change control.
• Created and analyzed quality metric reports and trend analysis.
• Team member for eCTD implementation and the corporate site quality council.
• Lead several task forces such as organic impurities, CPSC regulation, inorganic impurities (heavy metals), USP 61 and 62 harmonization, melamine and implementation of Sparta Systems.

Novus Fine Chemicals, Carlstadt, N.J, Director, Quality Assurance-Regulatory Affairs, 1999 - 2001

• Responsible for start-up Quality operation activities for active pharmaceutical ingredients, intermediates and resolving Warning Letter issues from previous ownership.
• Managed Drug Master File (DMF) and CMC regulatory, annual reports and submissions to FDA and international regulatory agencies.
• Lead, plan and reorganized quality assurance, validation, quality control, and regulatory affair departments.
• Manage and approve change controls, investigations, SOP's, validation protocols and reports.
• Manage internal and external audits, lead regulatory agency inspections, customer complaints, and managed consultants. Routinely interact with operations.
• Implemented training programs and conduct training sessions. Company contact representative for FDA and DEA regional district and lead for regulatory inspections.
• Agent for foreign API manufacturer. Managed a $750,000 budget and 25 employees.

Validation Team Leader

• Validation Team Leader, managed consultants and contractors in addition to Novus employees for Cleaning Validations, Process Validation, Master Plans, and IQ / OQ / PQ of production equipment.
• Oversight and managed the installation and validation of Deionized Water Carts, DI water system for API production, and Softwall curtain enclosures for parental products.
• Passivation equipment knowledge provided processing and training support. Implement quality systems and policies for document control, investigation, change control, laboratory operations, and product deviation reports.
• Performed gap analyses to identify non-compliance activities and remediate quality/operational processes and systems.
• The Warning Letter regulatory status of the facility was remediated in one year to a compliant facility status (NAI) with FDA.

Honors & Publications

Academic and Professional Affiliations

• American Society for Quality Training-ASQ
• American Chemical Society-ACS
• American Association of Pharmaceutical Scientists- AAPS
• Generic Pharmaceutical Association-GPHA
• United States Pharmacopeial-USP Committee

Publications and Patents

• Author of several text for educational and peer reviewed publications.

Education

• MBA Mercy College, Dobbs Ferry, N.Y.
• M.S. Organizational Leadership, Mercy College, Dobbs Ferry, N.Y.
• B.S. Biochemistry and Organizational Management, Mercy College, Dobbs Ferry, N.Y.