Conducting Effective GxP Investigations
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Speaker : Jamie Jamshidi
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When : Friday, February 21, 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.
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.
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 investigations.
- Improve compliance and quality through effective documentation and follow-up.
Areas Covered
Module 1: Introduction to GxP Non-conformances
- Definition and Types of GxP (GMP, GLP, GCP)
- Understanding Non-conformances: Examples, Deviations, Out-of-Specifications (OOS), Out-of-Trend (OOT), and Incidents
- Impact of Non-conformances on Product Quality, Safety, and Regulatory Compliance
Module 2: Regulatory Requirements for Documenting Non-conformances
- Overview of Key Regulations: FDA, EMA, ICH, WHO, MHRA
- Good Documentation Practices (GDP) and their Importance
- Requirements for Documentation in GMP, GLP, and GCP Environments
- Case Studies: Regulatory Findings and Common Pitfalls
Module 3: Conducting Effective Investigations
- Investigation Process/Types: Initial Assessment, Investigation Plan, Data Collection, and Analysis
- Root Cause Analysis (RCA) Techniques: Fishbone Diagram, 5 Whys, Fault Tree Analysis
- Best Practices for Interviewing Staff and Gathering Evidence
- Documentation of Investigation Findings
Module 4: Corrective and Preventive Actions (CAPA)
- CAPA Regulatory Requirements and Guidance
- Developing Effective CAPA Plans
- Implementing CAPA: Roles, Responsibilities, and Follow-up
- Measuring the Effectiveness of CAPA
Module 5: Risk Management in Non-conformance Investigations
- Understanding Risk Management Principles: Risk Assessment, Risk Mitigation, and Risk Communication
- Prioritizing Non-conformance Investigations Based on Risk
Module 6: Continuous Improvement and Quality Culture
- Building a Quality Culture: Leadership and Employee Engagement
- Continuous Improvement through Lessons Learned
- Monitoring Trends and Metrics for Non-conformance
- Strategies for Sustaining Improvements
Q &A
Who Should Attend
CMC, Quality Unit (QA and QC), Regulatory Affairs Managers/Department Heads
Why Should You Attend
This course provides a detailed overview of Good Practice (GxP) non-conformances, their regulatory landscape, and effective strategies for conducting thorough investigations.
Participants will learn to identify, document, and manage non-conformances in compliance with applicable Current regulations, such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
The course emphasizes practical approaches to root cause analysis, corrective and preventive actions (CAPA), and continuous quality management systems (QMS) improvement.
Topic Background
Documenting non-conformances, including incidents, excursions, deviations, events, Out of Specifications (OOS), Out of Trend (OOT), and non-compliance, is required under GxP regulations throughout the entire product lifecycle. Conducting thorough investigations or evaluations of these non-conformances is not only a good practice but also mandated by current regulations.
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$160.00
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