Mr. Vikram Kulshreshta Post Graduate in Microbiology with over 28 years of experience in Quality Assurance & Regulatory Affairs.
Companies worked in - Lupin, Cadila Pharma, Alembic, Amoli Organics, Claris Injectables (Now BAXTER), with Global presence.
Expert in "Designing & implementing the Quality Systems", Qualifications & Validations,Trouble-shooting & CAPA implementation and Regulatory Affairs.
Well versed with International cGMP regulations, e.g. USFDA, MHRA, TGA, ANVISA Brazil, MCC- South Africa, COFFPRIS-Mexico, WHO-Geneva (Prequalification program).
Has Registered many Drug Substances & Drug Product dossiers to US, Europe and other regions. Expert in handling Post DMF Approval changes.
Consultant & Auditor- API & Formulation manufacturing companies for USFDA/EU Audit preparations, Helped the companies to get USFDA, EU & other Regulatory approvals. Conducts Pre-inspections Gap analysis & compliance. Handles USFDA Warning letters to ensure compliance as well as Post audit observations, to comply with the CGMP, using a holistic & risk based approach. Conducted Pre-USFDA Gap Analysis and ensured Compliance for Alkem laboratories (for two Formulation manufacturing sites), Nectar Lifesciences (for their API & Injectable Formulation manufacturing sites). Both the sites got USFDA approval.
Facility & Projects Validations & Qualifications - Facility, Equipment, Utilities & Processes Expert in implementation of Risk based approach in designing Quality Management Systems, Processes and Validations. Renovation of existing manufacturing facilities to make it Global Regulatory compliant (USFDA, EU, MHRA, PICS etc.). Software validation
Specialization APIs (Sterile & Non sterile), Formulations (Parenterals & Solid/liquid orals) manufacturing facilities Quality Management Systems, Validations & Qualifications CAPA Management Handling of Regulatory matters Data Integrity
Trainings Conducts Trainings as well as Interactive workshops in India and abroad on CGMP, Validations & Qualifications, ICH (Quality series), Technology Transfer, QMS elements etc. My Training workshops are attended by the seniors from all the big Pharma companies. For example in India, the participants are from the companies like – Sanofi, Abbott,Lupin, Aurobindo, Glenmark, Hetero, Torrent, Sun Pharma, Biological Evans, Cadila etc. Conducts In-house trainings for Employee for up-gradation of knowledge through real life examples using interactive sessions. Conducts Training Sessions for students in Pharmacy colleges Delivers session in Pharmexcil INDIA (Export Promotion Council of India).
Webinars in India & Europe on CGMP, Validations & Qualifications, ICH (Quality series), QMS.
The webinar covers the practical approach for Root causes analysis, using different tools which can be used for Root cause analysis, tracking/trending of Root cause as a tool for improvement & designing strong CAPA.
Like any other Validation studies, Cleaning validation has been considered as a Generic version in the list of Validations.