Negar Panahian-Jand is experienced consultant with a background in Quality Assurance and Regulatory Affairs. She has a strong background in cGMP, GMP, and GDP regulations and their applications in the pharmaceutical industry. With her consulting experience and educational background Negar adds depth to the QCI team.
Skills and Highlights
- Performed QA activities to ensure GMP compliance prior to releasing products to market. QA activities included preparing and reviewing Annual Product Quality Reviews, Master Production Documents (MPD), Drug Master Files (DMF), Batch Records, Test Methods, Change Control documents, Method and Process Validation, Quality Assurance Reports (QAR), evaluation of product transportation conditions, product complaint investigations, deviation reporting, and review of stability data.
- Reviewed manufacturer’s Certificate of Analysis (CoA) and Certificate of Manufacturing (CoM) against the Canadian Finished Product Specifications.
- Experienced with analyzing batch production records, product releases & Out-Of-Specification (OOS) results.
- Enabled product sampling, relevant testing as well as assessment of documentation required for product release.
- Collaborated with various departments and third party manufacturers to prepare Master Product Information documents.
- Conducted thorough investigations of out-of-specification results and performed root cause analysis in a timely manner.
- Prepared corresponding deviation reports and ensured that relevant Corrective and Preventive Actions (CAPAs) were implemented.
- Facilitated compliance by ensuring completion of change controls and prepared updated finished product specifications.
- Performed importing, distributing, or wholesaling activities to provide a full-consulting service in Regulatory Affairs as Canadian legal agent for various domestic and international clients.
- Co-hosted Health Canada GMP Audits.
- Compiled new Drug Establishment Licence (DEL), Site Licence (SL) applications, amendments and annual renewals of DEL and/or SL to Health Canada.
- Provided regulatory guidance to customers regarding the filing of their Drugs and Natural Health Products in Canada.
- Prepared FDA submissions (eNDC) for Natural Health Products in accordance with FDA and Health Canada requirements.
- Prepared various new Product Licence Applications (PLAs) and Amendments in Electronic (ePLA) format through Natural Health Product Directorate (NHPD).
- Tracked and maintained regulatory correspondence (Clarifax/IRN) to Health Canada within their guidelines and time frame.
- Reviewed and approved final product labels based on compliance with U.S. and Canadian labeling regulations.
- Reviewed method validation protocols/reports against ICH requirements.
- Wrote, reviewed, and revised Standard Operating Procedures (SOPs) and Quality Agreements to comply with the regulatory requirements for Drugs and NHPs.
- Post-Graduate Diploma in Pharmaceutical Quality Assurance & Quality Control, Academy of Applied Pharmaceutical Science, Toronto, Canada.
- MasterMaster of Science in Bioinformatics, University of the Sciences in Philadelphia, Pennsylvania, USA.
- Research Scientist in Biomedical Tissue Engineering, Harvard Medical School and MIT Research Laboratory, Massachusetts, USA.
- Bachelor of Science in Molecular and Cell Biology (Microbiology), Azad Tehran University, Iran.