GxP Quality Management System (QMS) from Discovery to Commercialization-New Paradigm
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Speaker : Jamie Jamshidi
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When : Friday, December 06, 2024
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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.
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.
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, embracing QMS as more than just a regulatory requirement is essential. It is a powerful tool for driving business success, fostering strong partnerships, attracting investment, and maintaining a competitive edge in the market. By integrating QMS into the company's culture, leaders can ensure that quality becomes a core value that supports every aspect of the business.
Areas Covered
Module 1: Introduction to Current GxP requirements and key focuses of good practice throughout all stages:
- Laboratory Practice (GLP)
- Documentation Practice and Development
- Clinical Practice (GCP)
- Manufacturing Practice (GMP)
- Distribution Practice (GDP)
- Regulatory Operation (RO for IND, IMPD)
Module 2: Integrated Quality Systems
- End-to-end integration of GxP Practices: Creating a seamless QMS by linking GLP, GCP, GMP, GDP, and GVP.
- Strategies for achieving holistic quality management across all stages.
- Digital Transformation in QMS: Utilizing digital platforms to enhance collaboration and transparency. How technology supports integrated quality systems and improves communication.
Module 3: Roles and Responsibilities within the GxP Quality Unit (QU)
- Understanding the GxP Quality Unit’s Functions
- Defining the roles and responsibilities of the QU across the product lifecycle. Best practices for fostering a culture of quality and compliance.
- Key activities, Oversight, and Collaboration with Other Departments.
- How QU should collaborate with R&D, non-clinical, clinical operations, manufacturing, and regulatory teams.
Module 4: Risk-Based Approach in Quality Management
- Critical Quality Attributes (CQAs): Identifying and prioritizing CQAs that impact product safety and efficacy. Techniques for monitoring and controlling CQAs throughout development and manufacturing.
- Quality by Design (QbD): Integrating QbD principles to design robust processes and products.
Module 5: Regulatory Harmonization and Global Standards
- Aligning with International Regulatory Standards: Overview of key global standards (e.g., ICH, EU, WHO) and their implications.
- Strategies for ensuring compliance across multiple regulatory jurisdictions.
- Agility in Compliance: Adapting QMS to keep pace with regulatory changes, especially for new therapies.
- Practical tips for maintaining compliance in a rapidly evolving industry.
Module 6: Interactive Q&A Session
- Open Forum for Questions and Clarifications.
- Addressing participant queries and real-world challenges.
- Sharing best practices and expert insights to reinforce learning.
Who Should Attend
Associates, Specialists, Managers, and all levels of the Leadership team.
Why Should You Attend
For startup biotech and pharmaceutical companies, there are several obstacles to implementing Quality Management Systems (QMS) and staying in compliance with regulations. Some challenges include financial constraints, budgeting for the cost of quality, ensuring drug safety and efficacy, and managing resources. In this course, we will present, review, and discuss the key components of a GxP QMS that can be applied from the discovery phase to transitioning to commercialization.
This course aims to help startups and early-stage biotech and pharmaceutical companies in establishing a QMS that complies with GxP regulations. It emphasizes cost-effectiveness and efficiency through the evaluation of system design, tools, and implementation steps.
Topic Background
The GxP Quality Management System (QMS) is a crucial framework within the biotech and pharmaceutical industries, ensuring compliance with regulatory standards across the entire lifecycle of a product, from discovery to transitioning to commercialization. With the advent of new technologies and methodologies, the paradigm of GxP QMS is evolving to meet the dynamic needs of the industry.
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$199.00
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