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.
  • Define and implement a process characterization strategy

Areas covered:

Day 1:

  1. 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
  2. Fundamentals of Statistics
    • Descriptive and Summary Statistics
    • Graphical Techniques
    • Null Hypothesis Statistical Testing
    • Confidence and Tolerance Intervals
    • Discussion/Questions

Day 2:

  1. Statistical Tests
    • Comparative Statistics
      • t-tests, ANOVA
    • Non-Parametric Tests
    • Regression Analysis
    • Determine Sample Size (Power Analysis)
  2. Application to Industry
    • Developing a Quality Risk Management Plan
    • Assay Validation
    • Setting Specifications
    • Pharmaceutical Development Quality System
    • Discussion/Questions

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

Who will Benefit:

  • Quality Managers
  • Assay Development Scientists
  • Quality Analysts
  • Research Scientists
  • Risk Managers
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(10:00 AM to 4:00 PM EST)
  • 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.
Day 02(10:00 AM to 4:00 PM EST)
  • 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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Elaine Eisenbeisz

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.

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 with a minor in Quantitative Management, Accounting. Elaine received her Master’s Certification in Applied Statistcs from Texas A&M, and is currently finishing her graduate studies at Rochester Institute of Technology. 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 currently is an investigator on approximately 10 proton therapy clinical trials for Proton Collaborative Group, based in Illinois. She also designs and analyzes studies as a contract statistician for nutriceutical and fitness studies with QPS, a CRO based in Delaware. Elaine has also worked as a contract statistician with numerous private researchers and biotech start-ups as well as with larger companies such as Allergan 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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

January 19-20, 2022, Virtual Seminar
(Registrations till October 30, 2021 - $1499)
(Registrations after October 30, 2021 - $1899)

$7,645.00

Group-Max. 10 Attendees

January 19-20, 2022, Virtual Seminar
(Registrations till October 30, 2021 - $7645)
(Registrations after October 30, 2021 - $9685)



Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.
Offers:
  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • We need below information to serve you better

     

    +1-888-717-2436

    6201 America Center Drive Suite 240, San Jose, CA 95002, USA

    Follow Us

    facebook twitter linkedin youtube

     

    Copyright © 2021 ComplianceOnline.com MetricStream
    Our Policies: Terms of use | Privacy

    PAYMENT METHOD: 100% Secure Transaction

    payment method