Falguni Modi Email and Phone Number
Manage Cell Therapy Development and Operations (CTDO) APQRs change control for global product regulatory and quality CGT. at
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Bristol Myers Squibb
Falguni Modi's Location
Edison, New Jersey, United States, United States
Falguni Modi's Contact Details
Falguni Modi work email
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Falguni Modi personal email
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About Falguni Modi
• Seasoned pharmaceutical Quality and Technical Operations executive with an established track record for developing organizations for delivering sustainable cGMP compliance, operational performance. • Expert in Cell Therapy Development and Operations (CTDO) Annual product Quality review (APQR) and Change Control.• Excellent cGMP, ISO, and R&D Compliance auditing experience in the pharmaceutical industry and with in-depth knowledge in FDA site inspection, auditing, change management, quality management system implementation, training, corrective and preventive action, root cause analysis, statistical process control, and vendor management. Comprehensive knowledge of US regulatory requirements with experience in global regulatory requirements. Skilled in establishing simple and effective quality systems that pass FDA investigations. Holds an outstanding inspection record and strong relationships with FDA representatives.• Strong leadership, negotiating, conflict resolution, organizational, interpersonal, communication, problem solving, decision making skills in Pharmaceutical, Generic, OTC.
Falguni Modi's Current Company Details
Bristol Myers Squibb
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Manage Cell Therapy Development and Operations (CTDO) APQRs change control for global product regulatory and quality CGT.
Falguni Modi Work Experience Details
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Associate Director, Global Product QualityBristol Myers Squibb Nov 2022 - PresentLawrence Township, Nj, Us• Present and discuss APQR filing strategy with senior management. Lead and deliver on GPQ department goals of Breyanzi and Abecma APQRs. Provide APQR process governance to cross-functional product quality leads team and effectively communicate objective status to leadership. Define, plan, engage, coach and, subsequently establish initial roadmap for Breyanzi and Abecma APQRs, with all stakeholders to meet tight regulatory deadlines. Oversee and manage all aspects of the coordination and generation of cell therapy APQR projects successfully. • Contribute to the acquisition and visualization of data to support the development of APQR reports and maintenance of the global process. Monitor and present global APQR metrics (safety, quality, delivery, engagement) status. Maintain readiness of the APQR process and product reports during regulatory agency inspections and internal/external audits.• Establish site APQR and CMO APQR process. Represent at CMO meetings to ensure oversight and compliance with regulatory standards. • Launch and lead yearly biologic product reports (YBPR) process for Cell therapy. Manage and coordinate YBPR process execution within network of internal and Canadian YBPR lead to ensure appropriate documentation is delivered in a timely manner. • Drive toward continuous improvement process by leading cross-functional teams to improve and learn from complex technical and regulatory APQR via lesson learned sessions; extract optimized results through skillful collaboration.• Provide regulatory guidance and oversight to timely closure on change control, deviation and CAPA deliverables in compliance with FDA regulations, SOPs, industry standards. Lead PQL unique product impact assessments template for event investigations to resolve deviations, understand process trends, and improve process performance. • Recruit, hire, develop, train, and support new hires.
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Senior Manager, Global Product QualityBristol Myers Squibb Sep 2020 - Nov 2022Lawrence Township, Nj, Us• Planning, Defining and Establishing completion roadmap for Breyanzi and Abecma APQRs. Successfully completed Cell Therapy Development and Operations (CTDO) Annual product Quality review Execution for ABECMA and BREYANZI. Leading multidisciplinary lesson-learned team focused on optimizing APQR execution process.• Supervising design, development, and progress of YBPR process. • Heading document metrices to oversee GPQ strategic and operational aspects. • Recruiting, hiring, developing, and training the new hires. • Leading the Annual Product Quality Review (APQR) process for Commercial Cell therapy Products to consolidate cross network data to develop a holistic view of quality elements for the key brands, track resolution of action items stemming from APQR and from various Quality and operational forums.• Single point of contact for the Quality organization for late-stage development and commercialization of pipeline products as well as marketed key brand product supply throughout the product lifecycle.• Planning and executing the Quality component of the Product Supply Strategy for late-stage development pipeline products, ensuring network PAI readiness. • Partner with cross-functional team to develop Technical Agenda and Regulatory Submission Roadmaps for Commercial brands. Partner with sites, Regulatory Leads to coordinate change controls.• Providing leadership and oversight to timely closure of eQRMS change and deviations. Manage and own documentation and change controls associated with key deliverables from initiation to closure in eQRMS to clinical and commercial documentation across multiple programs. Launch and Own change request in eQRMS as per approved change proposal. Execute and coordinate change approval and implement activity as per target date. Assign action activity to SME for change implementation and closure. Coordinate with regulatory to complete assessment and action for the change. Assign post approval action activity as needed.
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Senior Quality Assurance Process SpecialistMerck Dec 2019 - Aug 2020• Leverage qualifications to support the Labeling Process and Documentation Redesign (Microsoft Word & Excel) effort to execute all elements of the documentation lifecycle (development, revision, and or retirement). • Work closely with the Directors, Project Managers, Process Owners and Document Owners to ensure deliverables are executed against the prescribed timelines. • Support of implementation identified actions of implementation related actions and alignment with activities planned for effective resolution.
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Manager, Corporate And R&D Quality AssuranceVertice Pharma Mar 2018 - Dec 2019• Provide support for laboratory from project inception through successful filing, including working with multidisciplinary teams to ensure pharmaceutical development activities are planned and executed in compliance with GMP standards. Provide local quality assurance support to R&D organization.• Provide quality related support to all ANDAs manufactured and released from Contract research organization (CMO).• Represent Quality on multi-disciplinary pharmaceutical product development teams. Ensure project plans adequately address GMP and Quality departmental requirements and standards. Facilitate GMP Quality activities at site as well CMO related programs to ensure timely and compliant delivery of product and data. Review/approve GMP documents to ensure clinical material meet compliance expectations. Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.• Develop and implement systems to support the delivery of GMP projects. Work with analytical team during FDA related questions and lead FDA site inspection activities.• Support site teams responsible for designing, implementing, and monitoring the CMC Quality System supporting the development of Drug Products including FDA inspection.• Act as a main Point of Contact for Quality in support of GMP specific work related to site. Support method validations and GMP testing from analytical labs. Support method transfer activities to client sites. • Modify, enhance, and develop SOPs to continuously improve how site work is conducted in a GMP production facility, to improve how CMO based activities can be in compliance including batch release, investigations etc.• Manage the Stability Program. Develop strategy for developing stability and method performance monitoring programs for products. Perform Root Cause Analysis, working with analytical team when stability issues are found and develop an action plan for successful resolution.
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Senior Q/A Documentation/Regulatory Compliance SpecialistCorepharma Llc 2010 - Feb 2018Middlesex, Nj, Us -
Sr. Regulatory Compliance SpecialistImpax Laboratories 2010 - Feb 2018Hayward, Ca, Us• Serve as Site Process Owner for Change Control, APR, Document Control. Provide leadership and oversight to the Change Control process ensuring that change controls are properly assessed and approved prior to implementation and that all deliverables are met prior to closure while ensuring timeliness. • Provide oversight and leadership to the Document Control Quality System ensuring adherence to GMP, including records retention and management for the site, company SOPs and company’s customers. Act as documentation system administrator to include maintenance of files of official/approved documents and prepare management reports. Review revisions to SOPs, route documents for review and disposition. Maintain document tracking records and reports to include the routing of change request and the implementation of change order. • Interact with Regulatory Health Authority representatives during inspections. Develop responses to Regulatory Health Authority observations directly impacting the site OTC Quality Systems. • Lead, manage, mentor and develop QA team to support individual project Change Management and incoming, in-process and finished goods testing and batch release processes for all products dispatched. • Develop and report monthly quality metrics for change requests and tracking of Open and Closed change requests for GXP System. Support product transfer, site transfer activity, new product launch, inactivation and activation of product. • Work with the other departments and functions to assist them in preparing Change Request. Develop roadmap for all change via identifying key activities, outlining interdependencies and assigning action items.• Drive the APR process to assure reviews are performed in accordance with the quality system procedures and Health Authority regulations and corrective actions are implemented as necessary. Prepare Annual product report.• Create and revise labeling material and packaging component specifications. -
Sr. AssociateMerck 2007 - 2010• Performed review and approval for generated technical content for the Chemistry, Manufacturing and CMC for IND applications, their amendments and initial marketing applications as per regulatory requirements of US and Europe.• Verified and approved source document for analytical, process, characterization, stability, method validation and batch specification sources for regulatory filing using software including Documentum, Q-cats, GTMS, LIMS, Atlas, ELN, MIDAS• Coordinated the completion of the CMC sections with the Regulatory Affairs (CMC) for filings. Verified technical documents to meet the needs of CMC.• Provided QA GMP support through review and approval of stability study time points for early and late developments projects by identifying errors and resolving them with analytical chemist. Performed GMP review and approval of documents through API release. Reviewed pilot plant batch folders in accordance with CPDC SOP and cGMP requirement.• Managed project plans and milestones, followed up on activities.
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Quality Assurance AuditorAptuit 2006 - 2007Verona, Vr, It• Provided GMP support through review and disposition of Pre and post-executed packaging batch and review and approval of deviation and complaints reports.• Performed review and disposition of clinical supplies material (drug product, packaging components) for different countries.• Facilitated in Investigation of Deviations, Out of Specs, Product Quality Issues.• Worked on closeout for CAPA throughout Quality system. -
Quality Assurance AuditorActavis (Now Allergan) 2002 - 2006Dublin, Ie• Performed QA functions inclusive of review manufacturing records, identifying deficiencies and resolving them with production staff.• Audited records to ensure compliance with approved master formula, as well as, compliance with 21CFR part 211 Subpart F Production and Process Control.• Performed review and approving release status of batches to Packaging.• Performed investigation reports review of finished product and in-process materials. Provided GMP support in manufacturing, packaging, documentation. -
Quality Assurance AuditorTeva Pharmaceuticals Jan 2000 - Jan 2002Tel-Aviv, Il• Performed Quality Assurance functions including laboratory data review, product quality, and in-process and final release of product and compliance activities.• Performed quality audits, evaluations of raw material, packaging material to assure API manufacturing is conducted in accordance with cGMP's, conducted GMP, GLP audits. Evaluated and audited annual product reviews.• Provided audit services for incoming materials, in-process operations, finished products and packaging to demonstrate consistency with SOP's and cGMP's. -
Senior Quality Assurance ChemistAccumed Inc. Jun 1998 - Jan 2000Us• Performed Quality Assurance functions including supplier management, product quality, and compliance activities.• Provided support for developing, and improving the quality of raw materials. This included the evaluation of manufacturing facility, methodologies and processes, analysis of materials using prescribed analytical procedures. -
Senior Quality Assurance SpecialistTorrent Pharmaceuticals Ltd Jan 1991 - Jun 1994Ahmedabad, Gujarat, In• Provided Quality Assurance under the full GMP and cGMP criteria.• Involved in sampling and analysis of raw material, in-process samples and finished goods.
Falguni Modi Skills
Sop
Gmp
Validation
Fda
Quality Assurance
21 Cfr Part 11
Capa
Change Control
Gxp
Glp
Regulatory Submissions
Cleaning Validation
Regulatory Affairs
Regulatory Requirements
V&v
Standard Operating Procedure
U.s. Food And Drug Administration
Six Sigma
Fda Gmp
Abbreviated New Drug Application
Laboratory Quality Assurance
Pharmaceutical Industry
Quality Auditing
Vendor Management
Quality Management
Root Cause Analysis
Batch Release
Statistical Process Control
Method Transfer
Change Management
Site Inspections
Anda
Cmo Management
Cmc
Falguni Modi Education Details
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Rutgers Business SchoolPharmaceutical Management -
Gujarat UniversityPharmacy
Frequently Asked Questions about Falguni Modi
What company does Falguni Modi work for?
Falguni Modi works for Bristol Myers Squibb
What is Falguni Modi's role at the current company?
Falguni Modi's current role is Manage Cell Therapy Development and Operations (CTDO) APQRs change control for global product regulatory and quality CGT..
What is Falguni Modi's email address?
Falguni Modi's email address is fa****@****rma.com
What schools did Falguni Modi attend?
Falguni Modi attended Rutgers Business School, Gujarat University.
What skills is Falguni Modi known for?
Falguni Modi has skills like Sop, Gmp, Validation, Fda, Quality Assurance, 21 Cfr Part 11, Capa, Change Control, Gxp, Glp, Regulatory Submissions, Cleaning Validation.
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