James MacLaughlin has 26 years of experience as an FDA Drug Investigator and Compliance Officer (he retired from FDA in December 2015), which spans both the sterile and non-sterile manufacturing arena. He has a thorough knowledge of FDA Regulations and ICH Guidelines. He has supported remediation projects and certification of sustainable results from the FDA regarding inspectional findings (FDA 483), Warning Letters, and Import Alerts. His expertise includes mock Pre-Approval, and six system GMP audits to assess the company's inspection readiness for future US FDA inspections. Consulting services include performing mock FDA audits at drug manufacturing & testing facilities and CMOs, review of FDA 483 items (risk assessments) & assistance with appropriate CAPAs, and review/preparation of written responses for submission to the FDA regarding inspectional observations (FDA 483), and remediation services.

Performed many regulatory compliance audits and remediation work for Pharmaceutical, Biopharmaceutical and Medical Device Industries. Expertise includes Data Integrity Audits and Remediation, CAPA, BMR & BPR Reviews, CSV and Equipment Qualification (Manufacturing, Packaging and Laboratory), Utility Qualification and Control Systems Validation. Performed domestic and international Data Integrity Audits and created remediation plan for gaps identified in Laboratory and Manufacturing Systems. Created, reviewed and approved Change Controls, Event Reports, ALIR and CAPA.

Conducted US FDA Pre-Approval Mock Audits, M&A Due Diligence Audits, and GxP Compliance Audits for numerous GMP and Pre-Approval inspections of pharmaceutical and biological drug manufacturers, including API facilities. Assisted with FDA 483 observations & CAPAs and response letters to FDA; provided Warning Letter response review service. Assisted during FDA audits in the front conference room or back room during audits and offered various other GMP consulting services. Helped companies with WL and FDA 483 responses and status updates to the FDA for domestic and international drug companies. Helped companies to gain FDA approval who were placed on 'import alert' by the FDA due to integrity &/or product manufacturing &/or testing issues. Compliance Officer experience included reviewing inspection reports & evidence of GMP deficiencies and preparing Warning Letters and court documents for seizures and injunctions (Consent Decrees).

Performed as a Senior Investigator of the U.S. FDA's elite 'Dedicated Foreign Drug Inspection Cadre'. As a member of the foreign drug cadre, 100% of his inspections were performed at foreign pharmaceutical manufacturing and testing sites. He conducted over 150 pharmaceutical manufacturing site audits in 20+ countries. Provided On-Job-Training to foreign regulatory inspectors during various foreign inspections. Provided training & seminars to FDA Drug Investigators located in the FDA's Southeast Region (which covers six states). Performed six system GMP inspections, Pre-Approval & Post-Approval audits, For-Cause Investigations at API facilities, solid oral & semi-solid dosage facilities, sterile eye drops/solutions, and parenteral drug manufacturers. Inspections included both prescription & OTC drugs for humans and animals.

Dr. Mathew T. Thomas has 34 exemplary years of experience of serving in numerous regulatory, management, and leadership positions at the U.S. Food and Drug Administration (FDA). He retired from the FDA in June 2023, after his last posting from 2017 to 2023 as the Senior Policy Advisor for the Office of Scientific Investigations (OSI) in the Center for Drug Evaluation and Research (CDER), where he was responsible for leading the development, coordination, and implementation of compliance policy programs and strategic initiatives, and communicating on topics pertaining to data integrity, data quality, and regulatory sciences.

He is a Physician with thirty-four years of experience in FDA Regulatory processes governing medical product development, involving Clinical Research, and Basic Science Research. Served the U.S. Government in senior diplomatic, leadership, and management positions that required top-secret clearance. Trained in the Management of Lipid Disorders, Clinical Pharmacology, Public Health, and Regulatory Sciences. Knowledgeable of Good Clinical Practice (GCP), Bioequivalence (BE), Good Laboratory Practice (GLP), Human Subject Protection (HSP), Post-marketing Adverse Drug Experience (PADE) reporting, and Risk Evaluation and Mitigation Strategies (REMS). Conducted Bioresearch Monitoring (BIMO) Inspections in about 25 countries (inspections of sponsors, contract research organizations, clinical investigators, Institutional Review Boards (IRB), Radioactive Drug Research Committees (RDRC), and Bioequivalence studies).

Participated in Post-marketing Adverse Drug Experience (PADE) Reporting Compliance Inspections and drug-related Risk Evaluation and Mitigation Strategy (REMS) Compliance Inspections. Possesses expertise in regulatory review, report writing, guidance development, and policy development covering FDA-regulated drugs, devices, biologics, and tobacco products. Delivered training and presentations on behalf of the USFDA to domestic and international audiences. Supported clients, particularly in managing regulatory enforcement actions, which included prevention, remediation, and certification of sustainable results.

Mathew George has over twenty nine plus years of experience in Life Sciences, Project Management, Validation, Technical Services, and Quality including Sterile (injectable and ophthalmic), Non-sterile (solid and liquid) dosages and API Manufacturing. He held leadership positions at DuPont Merck, Pfizer USA and Pfizer India. Provided industrial expertise in the development of quality systems, implementation, validation strategies and good practices. Supported clients particularly in response and managing regulatory enforcement actions, which included prevention, remediation and certification of sustainable results. Experienced in Interim Control for Consent Decree (CD), Warning letter (WL), and 483 activities.

Performed many regulatory compliance audits and remediation work for Pharmaceutical, Biopharmaceutical and Medical Device Industries. Expertise includes Data Integrity Audits and Remediation, CAPA, BMR & BPR Reviews, CSV and Equipment Qualification (Manufacturing, Packaging and Laboratory), Utility Qualification and Control Systems Validation. Performed domestic and international Data Integrity Audits and created remediation plan for gaps identified in Laboratory and Manufacturing Systems. Created, reviewed and approved Change Controls, Event Reports, ALIR and CAPA.

Proven knowledge about SDLC, cGMP, GLP, GCP, GAMP, QA/QC, MHRA, EMA, ANVISA, MFDS, WHO, Health Canada, FDA, 21 CFR 210, 211, Part 11 Regulations, ISPE and ICH Guidelines. Worked as a Lead Auditor for Pfizer and written audit reports. Created Risk Assessments based ICH Q9, NIST and GAMP for various systems used in Pharmaceutical, Biopharmaceutical and Medical Device Industries.

Performed Compliance Audits for API Plants, reviewed Batch Records and remediated action items. Also, audited CMO and CDMO Facilities and performed Pre-Approval mock audit for Continuous Manufacturing Process and Control Systems. Provided 483 Responses and status update for US FDA Audits. Experienced in leading QMS platforms such as Trackwise, MasterControl, ETQ, and Veeva Vault QMS.

Collaborated with the Senior Leadership of Quality and Regulatory within the Medical Device Industry Business Unit and Regions, to implement and maintain a unified, flexible, efficient and robust Quality System. Maintained and updated Quality procedures and all other Quality Records (including Technical File, Device Master Records and Device History Records).

Quality Assurance experience within an FDA regulated industry, Devices or diagnostics. Working knowledge of 21 CFR820, ISO 13485:2016, MDD, IVD, MDSAP and other global regulations. Experienced with sterile medical devices.

Koshy George has 30+ years of experience in the pharmaceutical and biopharmaceutical industries, as well as a Cleaning Validation SME and co-author of the PDA TR-29 Cleaning Validation Technical Report. Cleaning Validation SME with hands-on experience in developing cleaning validation strategies, Remediation efforts to prevent Cross-Contamination, Reviews of Deviation, Investigation and CAPA, evaluating Quality Management Systems, authoring and reviewing Cleaning Validation Master Plans, Cleaning Validation Protocols and Reports, Enhancement of Cleaning Validation Procedures and conducting Training of personnel responsible for various Cleaning Validation activities. Performed GMP Audits and participated in Remediation Activities.

Conducted Compliance audits and remediated various Compliance issues for Cleaning Validation issues at various manufacturing sites. Evaluated cleaning practices, provided recommendations, assisted in investigations, and helped determine root causes and CAPA for CV failures at several manufacturing sites. Conducted GMP and Cleaning Validation Training Sessions for QC, QA, and Validation personnel. Authored, Reviewed and approved Validation Protocols and Reports, Non-Conformances, SOPs, Master Validation Plans, Gap Analysis, Cycle Development Protocols and Reports, Engineering Study Protocols and Reports, Commissioning and Qualification Plans and Reports, Requalification Protocols, and Reports.

Developed product-equipment matrix for the API manufacturing, Pharmaceutical Compounding, and Filling systems. Developed cleaning validation strategies for the site, Equipment Cleaning SOPs for drug products and drug substances, and initiated a program for the selection of new cleaning agents. Developed SOP for spray ball coverage tests and best practices for Cleaning Validation sampling. Authored IQ, OQ, and PQ protocols and reports for tanks, tunnels, blenders, mills, and other process equipment. Managed the CV project (CIP and COP) and developed the cleaning validation strategy for the Pneumococcal Polysaccharide bulk manufacturing facility for the vaccine facility. Participated in the development of upstream and downstream production processes.

Assisted the QC labs in developing the analytical techniques for testing and cleaning validation samples following GLP guidelines. Performed recovery studies for swabbing from several MOCs. Defended the site's cleaning validation practices to the FDA. Qualified several autoclave load configurations to meet European regulatory standards and supervised the activities of technicians performing the validation projects for autoclaves in media production. Qualified several incubators, chill rooms, hoods, Lyophilizers, and classified production areas. Developed SIP procedures for several reactors, fermenters, and skids. Performed media challenge studies for several aseptic production and filtration systems. Participated in the tech transfer, scale-up, and process validation projects.

Murugan Govindasamy has 30+ years of experience and has served lead roles in Engineering and Technology and Sterile, Non-Sterile, and Bio-Pharma manufacturing. He led the implementation of complex technology projects (Process Excellence Projects including MES, Track & Trace, Automated Visual Inspection Systems, and initiatives on introducing AI systems that digitalize and minimize Human Interactions). He solved manufacturing and packaging problems for a large pharmaceutical company for the last 25 years. Automation Engineer with extensive experience in advanced manufacturing technology platform development, implementation, operation, and maintenance, including solving complex manufacturing issues through Engineering Solutions. He was a Global Technology Leader who has traveled to and supported resolving complex problems for a worldwide network of 35+ manufacturing sites for the last 22 years.