Symmetric
  • TRAINING COURSES
  • IN-HOUSE TRAINING
  • CLIENTS
  • TRAINERS
  • BLOG
  • ABOUT US
  • CONTACT

Join Symmetric Newsletter

Sign up today so you don't miss any special offers, new events and pharma breaking news.

TOP 3 Pharma & Biotech Worldwide News Once a Month

Interviews With Industry Professionals Once Every Three Months

Regular Event Calendar & Special Offers Once Every Six Months

Symmetric s.r.o.

Mliekarenska 7

82109 Bratislava

Slovak Republic

ID: 47 068 124

VAT No: SK2023741973

Office: +421 948 262 346

LinkedIn

Booking & Support

Phone (EU):+421 948 262 346 (9:00 - 17:00 CET)

Phone (US):+1 857 392 2714 (9:00 - 16:00 ET)

Email:info@symmetric.events

A real member of our team answers our chat

Terms & ConditionsPrivacy PolicyChange Your Cookie Consent

© 2026 Symmetric s.r.o.

Statistical Methods Across the Product/ Process Lifecycle
CMC
Pharma & Biotech
Scale up

Statistical Methods Across the Product/ Process Lifecycle

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

The most common and powerful statistical methods and their primary sue across the product lifecycle

The most common and powerful statistical methods and their primary sue across the product lifecycle

Learning Objective

The relationship of statistical methods and Quality Risk Management (QRM)

The relationship of statistical methods and Quality Risk Management (QRM)

Learning Objective

Key reasons to use Deign of Experiments (DOE) for process development

Key reasons to use Deign of Experiments (DOE) for process development

Learning Objective

Modelling populations to assure quality

Modelling populations to assure quality

Learning Objective

Difference between hypothesis testing and equivalence testing for comparability

Difference between hypothesis testing and equivalence testing for comparability

Learning Objective

Understanding the components of a sampling plan and associated acceptance criteria for Process Validation batches

Understanding the components of a sampling plan and associated acceptance criteria for Process Validation batches

Learning Objective

Distinguish between intra- and inter- batch variability and methods to assess each

Distinguish between intra- and inter- batch variability and methods to assess each

Learning Objective

Elements and nuances of an Ongoing Process Verification (OPV) Program

Elements and nuances of an Ongoing Process Verification (OPV) Program

Learning Objective

Combination of root cause analysis with data visualization to speed root cause identification

Combination of root cause analysis with data visualization to speed root cause identification



KEY TOPICS

Integrating data analytics to accelerate development, improve processes and reduce risk
Ensure Quality by Design and Optimal Control Strategy
Sampling and Acceptance Criteria
Establishing comparability with equivalence testing
Identifying Relative contribution of sources of variability
Data visualization
Ensuring ongoing quality

TRAINER

Tara Scherder

Tara Scherder

SynoloStats, USA, Principal

Tara Scherder has over 20 years’ experience in the pharmaceutical and biopharmaceutical industries as a statistician, engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes, and reduce risk. She combines statistical expertise with extensive knowledge of manufacturing platforms/analytical sciences and CMC requirements, always within business and regulatory context to achieve goals. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University.

Learn More →