Sign for Notice Everyday    注册| 登陆| 友情链接| English|
主页 添加事件 2025年会议 2026年会议 主题查询 国家查询 联系我们

Our Sponsors


    Statistical Elements of Implementing ICH Quality Guidelines

    View: 6

    Website https://www.complianceonline.com/statistical-elements-implementing-ich-guidelines-seminar-training-8 | Want to Edit it Edit Freely

    Category pharmaceutical; biotechnology

    Deadline: December 03, 2025 | Date: December 03, 2025-December 04, 2025

    Venue/Country: Virtual Online Seminar, U.S.A

    Updated: 2025-11-06 16:23:50 (GMT+9)

    Call For Papers - CFP

    This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn statistical methods related to ICH guidelines and will discover how regulatory agencies, such as the FDA expect organizations to meet these guidelines.

    Areas covered:

    Day 1: ICH review and Statistics Fundamentals

    Review ICH Quality Guidelines (Q Series)

    Q1 Stability Testing

    Q2 Analytical Validation

    Q3A-3E Impurities

    Q4 Pharmacopoeias

    Q5A-5E Quality of Biotechnological Products

    Q6A-6B Specifications

    Q7 Good Manufacturing Practice

    Q8 Pharmaceutical Development

    Q9 Quality Risk Management

    Q10 Pharmaceutical Quality System

    Q11 Development and Manufacture of Drug Substances

    Q12 Lifecycle Management

    Q13 Continuous Manufacturing of Drug Substances and Drub Products

    Q14 Analytical Procedure Development

    Developing a Quality Risk Management Plan

    Fundamentals of Statistics

    Normal Distribution

    Descriptive and Summary Statistics

    Graphical Techniques

    Null Hypothesis Statistical Testing

    Confidence and Tolerance Intervals

    Statistical vs. Meaningful Significance

    Day 2: Statistical Tests and Applications to Industry

    Statistical Analyses

    Comparative Statistics

    Regression Analysis

    Sample Size (Power Analysis)

    Discussion/Questions

    Application to Industry

    Design of Experiments (DOE)

    Setting Specifications/Thresholds/Acceptance Criteria

    Stability/Shelf-Life Testing

    Assay Validation

    Impurities

    Discussion/Questions

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.