Artificial Intelligence (AI) impact on Quality organization and regulations
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Speaker : Jamie Jamshidi
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When : Friday, November 01, 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.
This course is designed to equip Quality Units (QU) within GxP (Good Practice) regulated organizations with the necessary tools and knowledge to maintain compliance with both local and international regulations. By leveraging AI systems, participants will learn how to enhance daily functions, streamline processes, and uphold the highest quality and compliance standards.
Areas Covered
- Understanding GxP Regulations: Gain a comprehensive overview of GxP regulations and their impact on quality management.
- AI Integration: Learn effective methods for integrating AI systems into quality management processes to enhance efficiency and accuracy.
- Compliance Maintenance: Discover strategies for ensuring ongoing compliance with local and international regulations through the use of AI tools.
- Roles and Responsibilities: Clarify the roles and responsibilities within the Quality Unit to facilitate the successful implementation of AI-driven solutions.
- Introduction to AI: Explore the fundamental functions, features, and tools of AI, as well as its development.
- Overview of the Modern GxP Quality Unit (QU) and AI's Role: Understand how AI is increasingly vital in supporting GxP compliance throughout drug development, manufacturing, and distribution processes. This course will delve into ways to leverage AI in this context.
- Roles and Responsibilities of the GxP QU Related to AI Utilization: Explore the responsibilities of the GxP QU from early non-clinical phases to commercial transition in the context of AI utilization.
- Review of Selected Functions such as:
- AI Tools and Platforms for Quality
- AI System Validation or Qualification
- Data Integrity
- Documentation and Record Keeping
- Training and Qualification
- Non-conformances and Investigations
- Trending
- Advanced Process Control and Performance
- Risk Management and Mitigation
- CAPA
- Audit and Inspection Observations - Implementing AI Systems in QU
- Selecting the Right AI Tools for Your Organization
- Integrating AI with Existing Quality Management Systems
- Case Studies of Successful AI Implementation in GxP Environments
- Q&A
Who Should Attend
Quality Unit (QU), including Quality Assurance, Quality Control CMC, and Regulatory Associates, Managers, Directors, and Department Heads.
Why Should You Attend
As AI technology continues to evolve, its role in Quality will likely expand. Future developments may include more sophisticated AI models, greater integration with devices, and the use of AI in real-time monitoring and decision-making.
This course sets the stage for exploring the various applications, benefits, and challenges of using AI in GxP Quality Unit (QU), helping participants understand the transformative potential of AI in ensuring high-quality standards in modern industries. In the Bio/Pharmaceutical and Device industry,
AI is playing an increasingly vital role in assisting with GxP compliance across various stages of drug development, manufacturing, and distribution. In this course, you will explore ways to utilize AI.
Topic Background
Staying current with GxP regulations requires continuous improvement due to the dynamic nature of regulatory environments. GxP regulations (Good Practice regulations) encompass a range of guidelines and standards designed to ensure product quality and safety in industries such as pharmaceuticals, biotechnology, and medical devices. These regulations are constantly evolving to address new scientific discoveries, technological advancements, and emerging risks.
Therefore, organizations must continuously improve their processes to stay compliant. Artificial Intelligence (AI) can significantly enhance the functions of a Quality Unit (QU) by automating routine tasks, providing predictive insights, and ensuring data integrity.
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$199.00
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