Product Disposition Process from a GxP Point
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Speaker : Jamie Jamshidi
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When : Tuesday, March 18, 2025
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Time : 01 : 00 PM EST
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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.
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 requirements before it is administered to trial participants. This process ensures that the IP is safe, effective, and ready for use in clinical trials. This course will provide a detailed overview of the key steps involved in the IP release process for clinical use, covering every aspect from manufacturing to final release. Additionally, we will discuss IP disposition, which involves managing the final status of investigational products after their use in a clinical trial. This includes ensuring that all IPs—whether used, unused, expired, or damaged—are properly accounted for and managed according to regulatory and study-specific requirements.
Areas Covered
Introduction
- Quality Assurance (QA) disposition of investigational products (IPs) lots
An overview
- The release process of IPs for clinical trials
- Critical step ensuring the safety, quality, and compliance of the product before it is administered to trial participants.
Manufacturing and Initial Quality Control
- The investigational product is manufactured according to Good Manufacturing Practice (GMP) standards.
- Including strict adherence to approved protocols, standard operating procedures (SOPs), and Master Batch Records.
Quality Assurance Review
- Batch Record Review
- Deviation and Change Control
- Product Release Testing
Certification and Batch Release
- Qualified Person (QP) Certification
- Certificate of Analysis (CoA)
Packaging and Labeling
- Labeling and Packaging Requirements
- Blinding
Release Authorization
- Regulatory Compliance Check
- Release by QA/QP
Distribution
- Logistics and Shipping
- Receipt and Storage
Ongoing Monitoring and Accountability
- Site Monitoring
- Reconciliation and Destruction
Q & A
Who Should Attend
CMC, Quality Unit (QA and QC), Regulatory Affairs Managers
Why Should You Attend
This course is focused on Investigational Product disposition for Clinical trials. Gives a comprehensive overview of the relevant GxP regulations, the necessary steps to follow, documentation requirements, and processes for releasing product lots for clinical use.
The responsibilities of the Sponsor’s Quality Unit (QU) for GMP product manufacturing, testing, labeling, packaging, and release will be reviewed and discussed during the course.
Topic Background
For each batch of an Investigational Product (IP) at all stages of production, the Quality Unit (QU) must review the Batch Production and Control Records (BPCR), a collection of records that includes manufacturing instructions/parameters, analytical testing, and supplementary documentation before deciding on its use in clinical trials.
This decision, known as disposition, is based on a review of predetermined manufacturing and, if applicable, testing records to determine whether the product batch can be used for its intended purpose.
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$160.00
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