Dilipkumar P.'s Location
Greater Cleveland, United States, United States
About Dilipkumar P.
Hi, I’m Dilipkumar Patel , I am utterly devoted to creating positive impacts in people’s lives by building delightful, sophisticated, and above all *valuable* products compliance per FDA requirements. I am relentlessly seeking the magical mélange of a thorny problem and an emerging technology and am equally dogged in dodging all the BS that besets that path. I tirelessly hew to the skeptical-optimist line.My professional journey began with API manufacturing, took a long and winding path through various life science startups via bioinformatics, and has now returned me to Quality and complience in the age of the LLM.I believe in the preeminence of time in human life, and that all meaning and value flows from it. I love technology, but I am no technologist; I love science as method, but not science as dogma.I think hard about everything and I try not to let being too clever get in the way of being effective. I don’t put anything before impact, and I always strive to learn better and faster ways to bring it forth. Working knowledge and/or experience working in,Microsoft Visio,IQMS, ERP, SAP, AS400, Visma , Oracle , Master Control , 1 2 3 Compliance , Track wise ,Jira project management tool Formal Risk Assessments, Risk Mitigation Strategies, FMEA Process Validation of Sterile and Non-Sterile Product API manufacturing , Project coordination Qualification and validation Mock Pre-Approval Inspections (PAI) and Mock FDA Audits Deviation, CAPA, Audit Finding, Investigation Management Specialist GxP Audits (GMP, GCP, GLP) Vendor/Supplier Audits Drugs and Biologics: IND,NDA,DMF,ANDA and BLA, eCTD, Trial Master File (TMF), Regulatory information management systems (RIMS) FDA: 483’s, Warning Quality Standard: IEC, ISO 13485, ISO17025,ISO9001, 21CFR820 (design control processes)/ ISO 14971 Quality Systems and Standards: Site Master File, Specifications, STP, GTP, ATDS, Master Production Record, Validation Protocols, Master Plan, SOP Medical Devices & Diagnostics: 510(k), PMA, IDE, CAPA, FMECA, MDUFA, HUD, Design Dossier, CE Technical Files
Dilipkumar P.'s Current Company Details
Akshar Pharmamed Compliance Llc
Senior Regulatory Affairs Associate at Abbott
Cleveland, OH, US
Dilipkumar P. Work Experience Details
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Akshar Pharmamed Compliance LlcCleveland, Oh, Us
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Quality & Regulatory Compliance ConsultantAkshar Pharmamed Compliance Llc Nov 2021 - Present• New Drug Submission (NDS)/ Abbreviation New Drug Submission (ANDS)• DIN Application (DINA, DINB, DIND, DINF)• Clinical Trial Applications (CTA) and Amendments (CTA-A)• Supplement to a New Drug Submission (SNDS)/ Supplement to Abbreviated New Drug Submission (SANDS)/ Notifiable Change/Annual Notification• Gap and quality performance analysis.• Quality System Documentation• Audit and inspection Readiness and Remediation
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Senior Regulatory Affairs AssociateAdvance Clinical May 2021 - Oct 2021Abbott Park, Illinois, Us -
Quality & Regulatory Compliance ConsultantAkshar Pharma Med Compliance Llc Feb 2017 - Dec 2020• Authors, and reviews Master batch records, SOP, Protocols and subsequently develops protocol reports to support manufacturing/packaging events, deviations/CAPAs/OOS.• Prepares, reviews and approves regulatory submissions (i.e. NDAs, amendments, annual report, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s.• Support Doc Control, Change Control, Deviation Management, APR’s, Auditing, Laboratory, Complaints, Reprocess, Recalls and Supplier Qualification.• Produce high-quality investigation documentation that meets applicable standards and is appropriate for its intended audience. Accurately assess the manufacturing or analytical environment and independently conceives and initiates appropriate corrective/preventative actions (CAPAs) designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.• Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. URS,DQ, IQ, OQ, PQ,), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.• Utilize problem solving techniques and teamwork building strategies to Provides technical assistance to area supervisors or managers to solve complex problems. Exercise’s judgment in developing practices, techniques, and evaluation criteria for obtaining results.• Perform actions associated with change control documents and Corrective/Preventive Acton’s (CAPA) at in-house and CMO facility, provide updates to CMO for all records associated with CC, adverse events.• Knowledge and experience of CMC activity in medicine development and post approval management.
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Quality Assurance And Regulatory SpecialistRising Pharmaceuticals, Inc. Oct 2016 - Feb 2017East Brunswick Township, New Jersey, Us• Responsible to handle Product Quality Complaints, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions into post marketing product quality surveillance.• Assemble ANDA submissions ,working directly with CMO’s and development partners. • Manages data change request, Project update , Drafts and executes quality SQL data scripts and queries for production data updates and reporting , Labeling change request using Microsoft Visio application.• Prepare post marketing reporting such as 15-Day MedWatch’s, Periodic Safety Reports, compiling relevant information provided by partners and CMO’s , NDC number and assignment and associated FDA labeling related regulations for assigned products.• Prepare for submissions: Original ANDA’s, Prior Approval Supplements, CBE-30s, CBE-0s, Annual Reports, etc.• Perform actions associated with change control documents and Corrective/Preventive Acton’s (CAPA) at in-house and CMO facility , Provide updates to CMO for all Records associated with CC,CAPA, adverse events .• QA interface with third party PV provider and CMO for drug product complaints, inquiries and adverse events Coordinate return of samples, evaluation of samples, and shipment of samples to Contract Manufacturers.• Lead Labeling Working Groups (LWGs) and Labeling Committee (LC) for consensus and agreement on labeling revisions, assist in issuing CCDS updates, preparing USPIs/EUPIs for submissions, and assist with responses to health authority queries/comments.• Evaluate and manage the Technical CMC dossier documentation involved in change requests (including manufacturing site transfers) of pharmaceutical products.• Assist in the development of processes, policies and standard operating procedures to be used across the company relating to compliance audit and monitoring -
Quality EngineerFluke Biomedical Apr 2015 - Oct 2016• Managed all aspects of the supplier assessment process; develop audit plans/agenda, coordinate and conduct supplier audits as a Lead Auditor, prepare audit reports and review and approve supplier CAPA plans to ensure timely closure of audits • Compile, organize, file, retrieve, research and maintain department documents, submissions, logs and records in both hard copy and electronic formats and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan(e g 510(k), PMA, MDD Technical Files/Design Dossiers, global registration applications, etc.) • Authored and executed eMDR project and activate production account with FDA, responsible for all eMDR submission and related issue. • Perform GAP Analysis ,review and modify documents like SOP, Site master file, Design specifications, DHR, DMR, QIP, Quality Management Systems (QMS) , Quality Risk Management (QRM) , Microsoft applications, which includes working with templates, and editing and formatting complex documents.• Worked on design and implementation of a UDI for medical device units with understanding the GUDID (Global Unique Device Identifier Database) and the FDA requirements. Knowledge on how to determine the feasibility of adding a UDI to a device and not affect its proper operation.• Worked with internal and external business partners to assist in classification registration products in the U.S., EU and international markets.• Worked with internal team to help drive continuous improvements in completion and data gathering for technical files and standard technical documents development process• Reviewing labeling for display of written, printed, or graphic matter upon the immediate container of any article. Work closely with outside services such as translation houses, designhouses, Follow-up with vendor for IFU creation and Language Translations.
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Quality&Production CoordinatorMedical Product Laboratories Inc. Jan 2014 - Apr 2015• Interaction with other cross functional roles in the delivery and management of labeling text through the appropriate processes and systems. Review, develop and deliver core/local labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions.• Provided QA review and approval of contract manufacturing deviations, Product Complaints, SOPs, Change Controls, training documentation, field alerts and protocols/reports. Ensure completeness, accuracy and compliance of all documentation.• Actively worked on various ANDA project: prepared, organized all modules documents for filing to regulatory agency in a view of approved checklist.• Created and execute commissioning protocols (FAT, SAT), validation protocols (DQ, IQ, OQ, PQ) for process equipment, facility and utility systems.• Manage non-conformances and CAPA system. Lead corrective action/root cause investigations. Ensure timely close out of non-conformances and CAPAs, and ensure that corrective actions and preventative actions have been closed and implemented.• Maintain FDA readiness by maintaining Organizational Chart, list of approved products, product numbers, annual volume, and distribution, list of currently approved SOPs, list of approved CMOs; and in general, ensure the currency and accuracy of records used in support of FDA inspections.• Supporting quality inspector for routine inspection during processing on sharp floor. • Coordinates with Operations, Product Development and other Quality Control groups to assure accurate and timely completion of projects.• Responsible for reviewing and modifying documents like Master Production Record, Process documents, log books for completeness and compliance with effective SOPs to ensure the strength, identity, safety, purity and quality of the product
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Quality & Regulatory HeadSuleshvari Pharma Dec 2011 - Sep 2013Bharuch, Gujarat, In• Utilize problem solving techniques and teamwork building strategies to meet or exceed the facility key operating statistics.• Responsible for implementing and maintaining safety standards as required by law and company policy.• Actively worked on various DMF project: prepared, organized all modules documents for filing to regulatory agency in a view of approved checklist.• Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC. • Ensured facility and product registrations, product recalls and investigations were documented and maintained appropriately to help ensure a constant state of inspection readiness• Provided regulatory guidance to product development teams and drove strategic regulatory implementation via proper design controls throughout the product development process• Interfacing with cross-functional representatives as appropriate to manage the dossier preparation process and ensure all aspects of the plan are coordinated and executed efficiently.• Provide the quality presence and in-put to Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.• Ensure that Change requests, either from the External Supplier or from Client, are managed according to the Quality Agreement and Client SOPs from receipt, through to the implementation and closure.• Worked in partnership with Supply Chain Management, site manufacturing operations, research and development, quality control and assurance, engineering, maintenance management and support areas to solve problems and provide expertise on compliance issues related to contract manufactured products • Develop qualification and validation deliverables, such as FAT, SAT, IOQ, URS, VP, TM.• -
Deputy General Manager (Quality & Api Outsourcing Manufacturing)Apothecon Pharmaceutical Mar 2009 - Dec 2011• Responsible for auditing , reviewing ,maintaining Quality standard at CRO/CMO facility to check capabilities on quality systems and expectations, thorough product understanding, data trending and analysis on an on-going basis; checked equipment suitability for process and what is the GMP standard maintain in facility.• Actively worked on various ANDA, DMF project: prepared, organized all modules documents for filing to regulatory agency in a view of approved checklist.• Actively contributed to best practices and continuous improvement within Regulatory documentation; represented the group in functional and cross functional initiatives/projects when required. Coordinate preparation of CMC documents required for regional regulatory marketing applications, post approval changes, new clinical trial applications and quality amendments.• Commissioned new pilot plant for API manufacturing, Formulation plant for tablet, capsule, Injection, liquid filling. Selected equipment per R & D process, wrote, performed and reviewed validation protocol and report (URS, DQ, IQ, and OQ, PQ). • Conducted process and cleaning validation of sterile, non-sterile product (formulation and/or filling) coordinated with engineering for any specific design change in existing equipment’s.• Represented regulatory affairs requirements on R&D product development project teams to ensure all regulatory requirements are met throughout the development process • Responsible for development, planning, approval, and execution of project plans; organized and led meetings regarding project status, including project timelines, deviations, potential issues and corrective action resolutions • Managed and tracked the status of deviations, CAPA and Investigation associated to any Product complaint; demonstrated an emerging ability and developed innovative ideas for solving problems • Responsible for reviewing, modifying and approving documents like Master Production Record. -
Production ManagerIpca Laboretories (Formerly Known As Tonira Pharma) Ltd Jul 2007 - Mar 2009• Responsible for providing leadership and management to a busy Production Department and for ensuring the organizational effectiveness of the team. • Making sure the production team remains motivated and is hitting their efficiency targets.• Ensuring that staff at all times adhere to site safety procedures, Quality and HSE.• Identifying areas of waste and work with the team to reduce and eliminate them. Reducing stock levels without the risk of shortages or outages. Develop new procedures and processes to improve production accuracy.• Competently utilize Lean Manufacturing, Six Sigma, SPC and related process improvement techniques to ensure the most cost-effective manufacturing process.• Maximize effectiveness of production team, equipment and materials to produce multi-line products within planned schedules while reducing costs. Manage activities related to strategic purchasing to minimize operating expenses. Provide support to quality department on various DMF project for documentation for product registration. Review and advise suitability of documents to satisfy registration requirements. • Audited and reviewed CRO/CMO facility to check capabilities on quality systems and expectations, thorough product understanding, data trending and analysis on an on-going basis; checked equipment suitability for new or revised process, reviewing GMP standard maintain in facility. • Commissioning new Pilot plant, effluent treatment plant: selecting equipment per varies treatment process, development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports.• Partnered with manufacturing operations, providing compliance and technical guidance to ensure product quality issues are identified and resolved in a timely manner• Interpreted complex protocol to ensure documentation and operations meet requirements of cGMP,
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Production ExecutiveZydus Cadila Healthcare Limited (Formerly Known As Banyan Chemical) Jul 2004 - Jul 2007• Weigh, measure and check raw materials to assure batches manufactured contain proper materials and quantities.• Properly operate chemical charging system and glass-lined reactor, including the cleaning and maintenance of equipment.• Work with Managers to analyze job orders and develop production tasks and schedule. • Cost reduction of different drugs by checking % contribution of raw material ,theoretical yield and actual yield ,process time cycle ,by using recovered solvent in manufacturing process.• Recommend changes in workflow, operations and equipment to maximize production efficiency.• Manage and motivate production staffs to deliver exceptional work. • Establish and enforce company policies and safety procedures for staffs.• Followed, monitored, and recommended safety practices and procedures to production operators • Giving training to chemist /operator to operate equipment and handle process in good manner .• Ensure that final product meets quality standards and customer specifications.• Attend team meetings to discuss about production status and ongoing problems.• Verified all components used against batch records prior to, and during, operations • Instituted and monitored safe work practice procedures to maintain an injury-free and efficient production facility• Achieved a consistent record of improving production runs and reducing costs. Worked on project to reduce product cost by checking % contribution of raw material, theoretical yield and actual yield, process time cycle, using recovered solvent.• Performed all pharmaceutical equipment qualification activities, create and execute protocols (FAT, SAT), validation protocols (DQ, IQ, OQ, PQ) for processing, packaging equipment, and plant utility systems, • Developed an efficient workflow process by managing the supply chain, monitoring production by vendors, contractors and production staff.
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Production OfficerSun Pharmaceutical Industries Ltd Aug 2002 - Jul 2004• Involve in day to day production activity , Prepared BMR ,ECR ,validation protocol • Manage the reliability of process equipment including the preventive maintenance program, break downs, and corrective actions. Will recommend spare part inventories and perform failure modes and effects analysis (FMEA) for equipment and process• Giving training to operator to operate equipment , step wise entry in BMR , handling of critical process parameter • Tracking records for in process /intermediate and API sample ,• Compilation of result , final audit BMR and submission to QA dept.
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Production ChemistBanyan Chemical Ltd Jul 1995 - Aug 2002• Wear the appropriate PPE when working in manufacturing and other hazardous working environmentsTakes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors • Involve in day to day production activity , Prepared BMR ,ECR ,validation protocol • Giving training to operator to operate equipment , step wise entry in BMR , handling of critical process parameter • Submit in- process , intermediate and API sample during processing .• Ensure that materials are labeled properly and used in right quantities.• Compilation of result , final audit BMR and submission to QA dept• Prepare vessel utilization report and handover to supervisor • Coordinate prioritize and plan production tasks to meet deadlines.• Maintaining pH in ETP plant .• Suggest improvements for manufacturing procedures to achieve project objectives.• Develop standard procedures to improve quality and efficiency
Dilipkumar P. Education Details
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Dr.C.V.Raman University,Bilaspur, C.GOrganic Chemistry -
Vital Computer Center, Gujarat, IndiaComputer Software Engineering
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Gujarat UniversityChemistry
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The Maharaja Sayajirao University Of BarodaMathematics
Frequently Asked Questions about Dilipkumar P.
What company does Dilipkumar P. work for?
Dilipkumar P. works for Akshar Pharmamed Compliance Llc
What is Dilipkumar P.'s role at the current company?
Dilipkumar P.'s current role is Senior Regulatory Affairs Associate at Abbott.
What schools did Dilipkumar P. attend?
Dilipkumar P. attended Dr.c.v.raman University,bilaspur, C.g, Vital Computer Center, Gujarat, India, Gujarat University, The Maharaja Sayajirao University Of Baroda.
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