Why Should You Attend:
Most organizations have programs and procedures but they contain holes or fall short in the implementation of the tools and techniques used to apply proper statistical reasoning and analysis to ICH guidelines. Statistics can help you to better understand, implement, and track processes covered by the ICH guidelines?
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.
This seminar will provide attendees with an understanding of the fourteen ICH Quality guidelines as relates to statistical guidance and analysis. The course will provide tools, techniques and insight that will allow participants to immediately begin implementation of the information learned within their organization/firm
Learning objectives:
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
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
Who will Benefit:
- Quality Managers
- Analytical Validation scientists and personnel
- Assay Development Scientists
- Quality Control Personnel
- Quality Analysts
- Research Scientists
- Risk Managers
- 10:00 -11:00 AM
- Introduction to Clinical Project Management: Overview of project management; roles and responsibilities of the clinical project manager; establishment of project teams.
- 11:00 -12:00 PM
- 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.
- 12:00-1:00 PM Lunch
- 1:00-2:30 PM
- Process Mapping as a Planning and Management Tool.
- 2:30 – 3:00 PM Break.
- 3:00-4:00 PM
- 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.
- 10:00 -11:00 AM
- Costs Estimation, Creation and Management of Budgets: Effective project budget planning and tracking.
- 11:00 -12:00 PM
- Outsourcing Strategies. Vendor Management and Oversight: Qualification, selection, and oversight of vendors in clinical research projects.
- 12:00-1:00 PM Lunch
- 1:00-2:00 PM
- Tracking Projects: Risk, Cost and Change Management. Development and Implementation of Quality Control and Risk Management Systems and Key Performance Indicators.
- 2:00-2:30 PM
- Project Closure: Effectively closing a project and lessons learned.
- 2:30 – 2:45 PM Break.
- 2:45-3:45 PM 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.
- 3:45 – 4:00 PM Discussion of the Case study and Closing remarks
Elaine Eisenbeisz
Owner, Omega Statistics
Elaine Eisenbeisz is a private practice statistician and owner of Omega Statistics, a statistical consulting firm based in Southern California. Elaine has over 30 years of experience in creating data and information solutions for industries ranging from governmental agencies and corporations, to start-up companies and individual researchers. In addition to her technical expertise, Elaine possesses a talent for conveying statistical concepts and results in a way that people can intuitively understand.
Elaine’s love of numbers began in elementary school where she placed in regional and statewide mathematics competitions. She attended University of California, Riverside, as a National Science Foundation scholar, where she earned a B.S. in Statistics. Elaine received her Master’s Certification in Applied Statistics from Texas A&M and continues to learn from her practice. Elaine is a member in good standing with the American Statistical Association as well as many other professional organizations. She is also a member of the Mensa High IQ Society. Omega Statistics holds an A+ rating with the Better Business Bureau.
Elaine has designed the methodology for numerous studies in the clinical, biotech, and health care fields. She designs and analyzes studies as a contract statistician for pharmaceutical and proton therapy research. She also works on nutriceutical and fitness studies. Elaine works as a contract statistician with numerous private researchers, CRO’s and biotech start-ups as well as with larger companies such as Allergan, Intuitive Surgical, Guardant Health, Nutri-System, Amazon, and Rio Tinto Minerals.
Not only is Elaine well versed in statistical methodology and analysis, she works well with project teams. Throughout her tenure as a private practice statistician, she has published work with researchers and colleagues in peer-reviewed journals. Please visit the Omega Statistics website at www.OmegaStatistics.com to learn more about Elaine and Omega Statistics.
Local Attractions of Las Vegas, NV
Hoover Dam Supercar Tour
Drive four exotic cars on a thrilling round-trip guided road tour between the Las Vegas Strip and the Hoover Dam. During this supercar driving experience, you’ll get behind the wheel of four supercars. You'll discover for yourself what makes each so special.
Walking Gourmet Food Tours
Walking Gourmet Food Tours is a food tasting exploration of the many eclectic tastes of Las Vegas. Enjoy the highest quality food and drink at venues you might not have found on your own. From tasty appetizers and world-renowned entrees to signature cocktails and mouthwatering desserts, your taste buds will be tingling the entire time.
Vegas Indoor Skydiving
This is America’s first indoor skydiving built in 1982. Vegas Indoor Skydiving simulates the free fall aspect of skydiving without the use of an airplane or parachute. The experience is similar to skydiving with the addition of a mesh trampoline floor and foam padded walls.
National Atomic Testing Museum
The 10,000 square foot Atomic Testing Museum is one of the most popular museums in Las Vegas that is run by the Nevada Test Site Historical Foundation, and affiliated with the Smithsonian Institute. This museum is packed full of exhibits, movies, artifacts, and memorabilia relating to Nevada’s contributions to atomic energy research as well as providing a historical view of nuclear fusion and its impact on world politics.
Shark Reef Aquarium
Completed at a cost of nearly $60 million, the fully themed facility was designed with the idea of immersing the visitor into this underwater world in the desert. View a diverse cross-section of magnificent aquatic creatures, including 100 sharks, (15 species in all) along with exotic fish, reptiles and sea turtles.
The Mob Museum
The Mob Museum Las Vegas transforms one of the area’s most historic buildings and brings to life a fascinating chapter in the history of both the US and the city itself. It is an interactive Museum dedicated to the history of organized crime and law enforcement. The Museum presents a bold and authentic view of organized crime’s impact on Las Vegas history, as well as, its unique imprint on America and the world. If you are looking for something unique and off the strip in Las Vegas, the Mob Museum is it!
Freemont Street Experience
Located in Downtown Las Vegas, the Fremont Street Experience offers free nightly shows featuring 12.5 million lights and 550,000 watts of amazing sound at VivaVision. Enjoy free concerts and special events throughout the year. The world-famous, one-of-a-kind entertainment venue is home to Viva Vision, the biggest big screen on the planet. Ten legendary casinos line Fremont Street Experience with more than 60 restaurants and thousands of loose slots.
