Prakash SOJITRA profile

• Professional, having about 20+ years of experience working in Pharmaceuticals and Medical Device Manufacturing Companies. • Regulatory Affairs (Cardiac, Spine and Dental) • Quality Assurance and Compliance Management • Intellectual Properties • Experience in successfully designing to commercialization of 8 diversified drug delivering medical devices. (5 FDA IDE+CE and 4 CE). • Experience in GMP commercial manufacturing ready facility with validation and qualification and ISO17025 approved quality control laboratory with regulatory approvals for Drug / Medical Device Manufacturing. i.e., Non-sterile and sterile drug delivering medical devices, etc. • Experience in plant and analytical process validation, validation master plan, utility, and Sterilization Process Validation. (Steam and EO) • Knowledge and strong interpretation skills on various regulatory guidelines. (FDA 21 CFR Part 11, 820 HC, TGA, MHRA, ICH, ISO 13485, ISO10993, ISO 14971, ISO 14644, ISO 19011, OHSAS, APICS, WHO, USP, EP, etc.) • Management Representative: Function as Management representative, plan and execute internal audit, Quality Objectives and MRM. Keep up-to date QMS documents including work instruction, procedures, deviations, CAPA, NCR, calibration, change management and supplier audit. • Experience in handling internal audit, client, regulatory agencies (Such as EU, SFDA, TGA and USFDA etc.). • Hands of experience in reviewing biocompatibility, CMC, in vivo, invitro results test reports and ICH stability testing. • Risk Management: Overseeing the implementation of risk management processes (e.g. FMEA), risk register, including risk assessments and the development of risk management plans per ISO 14971. Review and approve risk management file documents. • Review and approval of quality issues (e.g., deviation, investigations) and technical matters (e.g., design changes, verification and validation protocols and reports) with impact to design control and risk management. As required, lead investigations, root cause analyses and CAPAs. • Regulatory Strategy: Developing and implementing regulatory strategies for the approval and commercialization of various drug / medical devices. • Communication with Regulatory Authorities: Interacting and communicating with regulatory authorities, such as the FDA, Notified Bodies, or other regulatory agencies. This includes responding to inquiries, addressing regulatory concerns, and participating in meetings or

Nanotechnology Controlled Drug Delivery Liposomal drug delivery Drug eluting stent Drug coated balloon

https://scholar.google.com/citations?user=EMB5yosAAAAJ&hl=en (https://orcid.org/0000-0002-4421-0806),