Astha Khanna
Head- Regulatory Affairs and Medical Writing
- Role
- Head, Regulatory Affairs & Quality Assurance at Graver Technologies, LLC
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Astha Khanna
Dr. Khanna is currently the Head of Regulatory Affairs, Quality Assurance & Product…
Experience
Head, Regulatory Affairs & Quality Assurance
Mar 2019 — Present · New York, NY, US
Medical Devices: Leadership experience in Class I, II and Medical Devices, Surgical Implants, IVDs, Combination products, Design Assurance, Quality Assurance, Risk Management, 510k approval, Interaction with FDA and global health authorities, Regulatory Strategy & Compliance, Design Controls, Manufacturing/Operations Quality, GMP, Process development & validation, Manufacturing transfers, Quality System compliance & performance, Inspections & audits, Reliability, Supplier Quality, Post-Market Quality, Complaint handling & management, Six Sigma, FDA QSR, ISO standards, R&D, New Product Development, Software Development Lifecycle (SDLC), ISO 13485:2016. Biologics and Small Molecules:Led several teams for Research Laboratory Operations (RLO) and prepared regulatory submissions including BLA, NDAs, INDs, CTAs, CMC and IND annual reports, safety reports and clinical protocols.Interface between Health authorities and the clients and also participated in all project team meetings internally and externally with clients/business partners throughout clinical development of drugs and medical devices.Expertise in preparing clinical study protocols (CSPs), protocol amendments, clinical study reports(CSRs), briefing documents, Investigator’s brochures (IBs), summary modules, clinical overviews/summaries towards submissions including INDs, NDAs, BLAs, MAAs,Extensive knowledge of US and international regulations, ICH requirements and guidance on clinical regulatory document preparation.Quality Assurance: ISO 9001:2015 QMS LEAD AUDITOR certified from BSI (British Standards Institution)Deemed Competent on- QM- Quality Management Systems (ISO 9001:2015)AU- Management Systems Auditing (ISO 19011:2018)TL- Leading Management Systems Audit Teams (ISO 19011:2018)
Education
Clemson University
PhD, Bioengineering
2011 — 2017
MD University, India
Bachelor of Technology (B.Tech.), Biotechnology
2006 — 2010
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