Speaker Profile
Jamie Jamshidi
Jamileh (aka Jamie) Jamshidi is a Quality Unit (QU) and Regulatory Operations (RO) professional with over 34 years of industry experience, including small molecules, large molecule biologicals, and peptides. Jamie's experience gained working in the US, EU & Asia in site and corporate roles. Jamie has held leadership roles in the Quality Unit (QU) and Regulatory Operations (RO) throughout the product lifecycle. She retired from Amgen, Inc., in 2007 after 17 years of service with the company. Some of Jamie’s major accomplishments include assisting with launching Amgen, Inc.’s first two commercial products, Epogen® and Neupogen®. Jamie was a key team member in the start-up of numerous new Amgen CGMP facilities in the U.S., Puerto Rico, and Europe. She helped establish several new departments at Amgen, including Contract Manufacturing and Small Molecule Quality Unit (QU). She was also instrumental in helping Amgen obtain approval for their first small molecule product, Sensipar®. Jamie was the key Amgen Quality Assurance (QA) representative at several FDA and other regulatory inspections at contract manufacturing sites. In March 2007 Jamie started PQC Consulting, Inc., and later in 2011, the Quality and Regulatory Management (QMR) consulting firm providing expert technical services, solutions, and training to pharmaceutical and biopharmaceutical companies worldwide. In January 2011 she was the Head of Training and Education for the BioScience Alliance (BSA) and the Head of the Quality Unit (QU) with Karyopharm Therapeutics. From September 2011 to Oct 2014, she was the Vice President (VP) of Quality and Regulatory Affairs, and the Quality & Regulatory Advisor at Karyopharm Therapeutics, Inc. Since Oct 2014, Jamie has been working with over 15 Startup companies assisting them with providing Quality and Regulatory Consulting. The key Consulting services including, support clients during all stages of a product’s lifecycle from discovery to commercialization, acting Head of Quality Unit (QU) and Regulatory Operation (RO), and Chief Compliance Officer (CCO) for start-up companies, overseeing the establishment, maintenance, and implementation of Quality infrastructure, system, and procedures, including non-clinical, clinical, and commercialization. She has extensive knowledge and expertise in the areas of product regulations, Quality Management Systems (QMS), Quality Unit (Quality Assurance and Quality Control), CMC Manufacturing, Validation, Analytical Labs, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, Outsourced Activities, Managing Contract Manufacturing, Technology Transfer, Audits, and Team Leadership. Jamie is the FDA subject matter expert (SME) that has studied pharmaceutical and Biotechnology regulations for over 34 years and has given numerous lectures and talks in the areas of Quality and Regulatory in several colleges, universities, and conferences globally. She is well known in the bio/pharmaceutical industry for her passion and respect for FDA and international laws and regulations.
Jamie Jamshidi
December 06 2024
01 : 00 PM EST
90 Minutes
GxP Quality Management System (QMS) from Discovery to Commercialization-New Paradigm
The new paradigm in GxP QMS reflects a shift towards greater integration, digitalization, and a focus on the patient. By adopting these advancements, biotech and pharmaceutical companies can not only ensure compliance but also enhance the overall efficiency, safety, and effectiveness of their products, ultimately benefiting patients and stakeholders across the value chain.For leadership across all levels, e..
Jamie Jamshidi
January 30 2025
01 : 00 PM EST
60 Minutes
Evaluating and Selecting Qualified Consultants for Quality organizations
Selecting the right consultant for a quality organization in biotech or pharmaceutical start-ups is a crucial decision that can significantly impact the company's success. The right consultant can provide valuable expertise, guide the development of robust quality systems, and ensure compliance with regulatory standards. This course is designed to offer a comprehensive overview of the key considerations for..
Jamie Jamshidi
February 21 2025
01 : 00 PM EST
90 Minutes
Conducting Effective GxP Investigations
By the end of this course, participants will be able to: Understand the different types of GxP non-conformances and their implications. Identify the key regulatory requirements for documenting non-conformances. Conduct effective investigations to determine root causes.Develop and implement corrective and preventive actions (CAPA).Use risk management principles to prioritize non-conformance investi..
Jamie Jamshidi
March 18 2025
01 : 00 PM EST
60 Minutes
Product Disposition Process from a GxP Point
IP disposition and release are essential aspects of clinical trial conduct. These processes ensure compliance with Good Practice (GxP) guidelines and regulatory requirements, maintaining the integrity, safety, and quality of clinical trial data. The IP release process involves several crucial steps to ensure the investigational product (IP) meets all necessary quality, regulatory, and protocol-specific requ..
Jamie Jamshidi
April 24 2025
01 : 00 PM EST
90 Minutes
Quality Unit (QU) Roles and Responsibility of Sponsor for Non-clinical and Clinical Studies
This comprehensive course is designed to provide an in-depth understanding of the evolving regulatory landscape and the critical role of the Sponsor's Quality Unit (QU) in non-clinical and clinical research. The course focuses on the enhanced responsibilities and requirements placed upon the QU to ensure compliance, integrity, and ethical conduct throughout the drug development process, from early-stage res..