Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering.
This training is designed for professionals in the pharmaceutical and biotechnology industries who are engaged in quality assurance, control, validation, and risk management. The program focuses on addressing the implementation gaps in ICH quality guidelines using statistical reasoning and analysis.
Learning Objectives and Outcomes
- Understanding ICH Guidelines: Trainees will gain a comprehensive understanding of the fourteen ICH Quality guidelines concerning statistical analysis.
- Statistical Tools and Analysis: The course covers normal distribution, hypothesis testing, confidence intervals, and other statistical methods pertinent to the pharmaceutical industry.
- Risk Management: Participants will learn how to develop and implement a quality risk management plan.
- Practical Application: The seminar includes practical applications of statistics in various areas, such as stability testing, assay validation, and impurity testing.
Key Topics and Structure
- Day 1: Focuses on reviewing ICH guidelines, understanding the basics of statistics, and developing a quality risk management plan.
- Day 2: Delves into statistical tests and industry applications, including design of experiments and setting specifications.
Training Format
- The seminar is spread over two days, with each day running from 10:00 AM to 4:00 PM EDT, covering both theoretical aspects and practical applications of statistical methods in compliance with ICH guidelines.
Expert Speaker
- Elaine Eisenbeisz: Owner of Omega Statistics and an experienced statistician, Elaine brings over three decades of expertise in statistical consulting to the seminar. She has a proven track record of collaborative and educational work across various sectors, including pharmaceutical research.
Training Goals and Regulatory Context
- The training aims to fill the knowledge gap in applying statistical methods to meet ICH guidelines, a key requirement from regulatory agencies like the FDA. It is structured to help organizations mitigate the risk associated with poorly designed studies and non-compliance.
Upon completion of the course, you will be able to:
- Compare FDA requirements to ICH guidelines.
- Perform comparative analyses and regression analysis.
- Know the difference between confidence and tolerance intervals.
- Calculate the appropriate sample size.
- Calculate the probability of risk.
- Design and perform statistical tests for comparisons, stability, validation, impurities
The course is most beneficial for professionals involved in Quality Assurance, Quality Control, Analytical Validation, Assay Development, Risk Management, and other related fields within the pharmaceutical and biotech industries.
SEMINAR AGENDA
DAY 1
- Introduction to Clinical Project Management: Overview of project management; roles and responsibilities of the clinical project manager; establishment of project teams.
- Strategic Project Planning: Review of the project charter; risk identification to clinical research projects; development of a project plan; creation of the work breakdown structure in a project.
- Process Mapping as a Planning and Management Tool.
- Effective Schedule Management: Defining project scope; creation of realistic schedules; identification of critical path to a project; effectively managing change orders and out of scope to your project.
DAY
- Costs Estimation, Creation and Management of Budgets: Effective project budget planning and tracking.
- Outsourcing Strategies. Vendor Management and Oversight: Qualification, selection, and oversight of vendors in clinical research projects.
- Tracking Projects: Risk, Cost and Change Management. Development and Implementation of Quality Control and Risk Management Systems and Key Performance Indicators.
- Project Closure: Effectively closing a project and lessons learned.
- Group work on the Case study
- Case Study: Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Techniques Applied to the Planning and Execution of a Clinical Trial.
- Discussion of the Case study and Closing remarks
For more information about this training visit https://www.researchandmarkets.com/r/ys7pw9
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