Laxman Reddy Chindala
Hyderabad
Summary
Proven expert in Computer System Validation and Risk Assessment with a strong track record of enhancing regulatory compliance at Clian Labs. Successfully led cross-functional teams in validation projects, ensuring 100% audit readiness. Adept at stakeholder communication and navigating complex regulatory environments to drive project success. Aiming to leverage expertise to further optimize compliance strategies and operational efficiencies.
Overview
11
11
years of professional experience
Work History
Clians Labs Private Limited
Hyderabad
04.2018 - Current
- Develop and execute validation plans for computerized systems in compliance with FDA, GxP, and industry regulations
- Prepare key validation documents, including User Requirement Specifications (URS), Functional Requirements Specifications (FRS), and Validation Plans (VP)
- Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing
- Perform risk assessments and gap analyses to ensure compliance with regulatory standards
- Collaborate with cross-functional teams (IT, QA, Manufacturing, and R&D) to validate software applications, laboratory instruments, and enterprise systems (ERP, LIMS, MES)
- Maintain validation documentation and manage Change Control processes for validated systems
- The following software validated: Clinical Trial Management System software, eCRF (Electronic Case Report Forms), Online Volunteer Information System software, Zentixs Software (E-Clinical Module, SOP module, Document Control Management, Training Module etc…), ECG machine Software, X-ray system software, Reporting Management System, Label software
- Conduct site initiation, routine monitoring and close-out visits
- Ensure clinical trial sites comply with study protocols, Good Clinical Practice (GCP) and regulatory requirements
- Verify the accuracy and completeness of case report forms (CRFs) against source documents
- Ensure compliance with FDA, EMA, MHRA and other regulatory bodies
- Assist in regulatory submissions and ethical approvals
- Maintain trial master files and essential documents
- Train investigators and site personnel on study protocols and GCP guidelines
- Ensure proper subject recruitment, informed consent process and data collection
- Monitor electronic data capture (EDC) systems for data accuracy and integrity
- Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs)
- Identify and mitigate risks affecting trial progress and compliance
- Conduct source data verification (SDV) and ensure site documentation accuracy
- Assist in audit preparation and site inspections
- Serve as a liaison between sponsors, investigators and regulatory bodies
- Participate in investigator meetings and site training sessions
- Preparation of monitoring visit reports
- Justification, Preparation and submission of regulatory query responses for studies and system
- Justification, Preparation and submission of sponsor query responses for studies and system
- Ensure the audit readiness and facing of regulatory audits and sponsor audits
- Preparation and Review of SOP’s
- Designing of clinical facility as per requirement (Screening Area: Volunteer waiting hall, BMI, ECG, Medical examination & Sample collection rooms, Informed consent areas, Clinical pharmacology units: Dosing, Vitals, Monitor, Physician rooms, Phlebotomy area and ICU)
- Procured required clinical software like Volunteer management system and Online verification system with Audit trails etc..., from vendors
- Procured required Clinical instruments and equipments (Humidity chambers, Deep freezers, Centrifuges, analytical balances and ICU instruments etc.)
- Exhibit the instruments installation process
- Exhibit instruments qualification (IQ), operational qualification (OQ) and performance qualification (PQ) qualification
- Review of instruments qualification (IQ), operational qualification (OQ) and performance qualification (PQ) documents
- Review of instruments calibration certificates
- Preparation clinical procedural SOP’s
- Preparation of instrument and Equipments SOP’s
- Preparation clinical software SOP’s
- Identification and evaluation of vendors
- Supported for QA to finalize the vendors
Clinical Research Associate
Apotex Research Private Limited
Bangalore
09.2015 - 03.2018
- Handling different type’s studies
- Preparation of Clinical study reports, Clinical study updates, Trial master file, Clinical raw data, AE summary and concomitant medication and lab data summaries
- Review of ICF’s and study documents which includes (CRF’s, TMF & Screening documents)
- Preparation CRF’s and eCRF’s for data entries
- Preparation of Docubridge and making of hyperlinks for CSR
- CDISC and Nuleap entries and review
- Continuous monitoring of studies with compliance of Protocol, SOP’s, GCP and applicable guidelines
- Query resolution management of the audits related to clinical aspects and other issues in co-ordination with quality assurance department
- Managed team for studies (Research associate team, Nursing staff & Phlebotomy staff)
- Participated in screening and volunteer counseling activities
- ICF presentations & obtaining, interaction with the volunteers Co-ordination of screening process
- Archival of study files after CSR dispatch
Clinical Research Associate
Ecron Acunova Private Limited
Mangalore
05.2014 - 09.2015
- Worked as Sub-investigator for handling different types studies
- Preparation of Clinical study reports, Clinical study updates, Trial master file, Clinical raw data, AE summary and concomitant medication summaries
- Review of ICF’s and study documents which includes (CRF’s, TMF & Screening documents)
- Preparation CRF’s and finalization CRF’s
- Review of study documents which includes (ICF’s, CRF’s, TMF & Screening documents)
- Submission of protocol and its appendices, study intimations, clinical updates, appendices, notifications, version histories and summary reports for EC approvals and information
- Continuous monitoring of studies with compliance of Protocol, SOP’s, GCP and applicable guidelines
- Revision of SOP’s according to the time lines
- Query resolution management of the audits related to clinical aspects and other issues in co-ordination with quality assurance department
- Managed team for studies (Research associate team, Nursing staff & Phlebotomy staff)
- Co-ordination with respective teams with relation to medical writing team, PV cell and QA
- Segregation and shipments of plasma samples to Bio-analytical departments as per the timelines
- Participated in screening and volunteer counseling activities
- ICF presentations & obtaining, interaction with the volunteers Co-ordination of screening process
- Archival of study Files after CSR dispatch
Education
M. Pharm - Pharmacology & Toxicology
National College of Pharmacy
Shivamogga, Karnataka12.2013
B. Pharmacy -
SVCP College of Pharmacy
Mysore, Karnataka08.2011
Skills
- Computer System Validation (CSV) – GxP, 21 CFR Part 11, Annex 11
- Validation documentation – URS, FS, DS, IQ, OQ, PQ
- Risk Assessment and Compliance – GAMP 5, FDA, and EMA regulations
- Testing and Verification – User acceptance testing (UAT), data integrity checks
- Audit and Regulatory Compliance – FDA, UK-MHRA, EMA
- Validation documentation – URS, FS, DS, IQ, OQ, PQ
- Risk Assessment and Compliance – GAMP 5, FDA, and EMA regulations
- Testing and Verification – User acceptance testing (UAT), data integrity checks
- Audit & Regulatory Compliance – FDA, MHRA, ISO 13485, GDPR
- Testing and Verification – User acceptance testing (UAT), data integrity checks, Audit and Regulatory Compliance – FDA, UK-MHRA, EMA
- Clinical Trial Monitoring – Site selection, initiation, routine monitoring, and close-out visits
- Regulatory Compliance – ICH-GCP, FDA, EMA, MHRA regulations
- Data Management – Source Data Verification (SDV), Case Report Forms (CRFs), EDC systems
- Risk-Based Monitoring (RBM) – Identifying and mitigating trial risks
- Adverse Event Reporting – SAE handling, pharmacovigilance principles
- Stakeholder Communication – Liaising with investigators, sponsors, and ethics committees
Personal Information
- Date of Birth: 03/26/90
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Languages
- English
- Hindi
- Telugu (W, R&S)
- Kannada (R&S)
Publications
- A REVIEW ON PHARMACOLOGICAL ACTIVITIES OF CARICA PAPAYA., Chindala Laxman Reddy and I. J. Kuppast, International Journal of Universal Pharmacy and Biosciences, 02/2013, 2(1), P 299-307
- A REVIEW ON BENEFITS AND USES OF VITIS VINIFERA (GRAPE)., Chindala Laxman Reddy, N.S.S.A Valli Kanagarla, and I. J. Kuppast., Research and Reviews in Bioscience, 04/2013, 7(5), P 175-180
- SELF-MEDICATION PATTERN AMONG PROFESSIONAL STUDENTS IN MALNAD REGION OF SHIMOGA DISTRICT: AN CONCERN., Chindala Laxman Reddy, I. J. Kuppast, T. Veerashekar. N. S. S. Vallikanagarla., Research and Reviews in Bioscience, 08/2013, 8(1), P 35-37
- STUDY ON EFFECT OF HAEMATINIC FORMULATIONS IN RECOVERY OF HAEMOGLOBIN OF FEMALE VOLUNTEERS IN MALNAD REGION OF KARNATAKA STATE., Chindala Laxman Reddy, N.S.S.A ValliKanagarla, I. J. Kuppast, T. Veerashekar., An Indian Journal Biochemistry
Extracurricular Activities
Watching and playing Cricket.
Training
- FDA 21 CFR Part 11 Compliance Training.
- Attended Training on 'Good Clinical Practices'.
- Attended Training on 'Good Laboratory Practices'.
- Attended Training on 'eCRF'.
- Attended Training on 'MEDRA'.
- Attended Training on 'CDISC' (Clinical Data Interchange Standards Consortium).
- Attended Training on 'BLS' (Basic Life Support).
Disclaimer
I hereby inform that all the above furnished details are true to my extent and if you are pleased with my profile and give an opportunity to work in your highly esteemed company, I will surely prove my efficiency in concerned work.
Conferences And Workshops Attended
- Diabetes education and prevention, Management of chronic obstructive pulmonary disease, 11/23/09 to 11/24/09, Sarada Vilas College of Pharmacy, Mysore
- Advanced Experimental Techniques in Pharmacology, 01/24/11 to 01/26/11, Siddaganga College of Pharmacy, B. H. Road, Tumkur
- Research paper poster presentation, 64th IPC, 12/2012, Chennai
Audit Experience
- Accomplished in FDA, EMA, AEMPS, ANVISA, GHC, NPRA, CHMP and DCGI audits.
- Accomplished in Ethics committee and sponsor audits.
Timeline
Clians Labs Private Limited
04.2018 - Current
Clinical Research Associate
Apotex Research Private Limited
09.2015 - 03.2018
Clinical Research Associate
Ecron Acunova Private Limited
05.2014 - 09.2015
M. Pharm - Pharmacology & Toxicology
National College of Pharmacy
B. Pharmacy -
SVCP College of Pharmacy
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