CMC Statistics
CMC Statistics

Course Description

Multiple ICH and regulatory agency guidelines applicable to CMC activities explicitly cite the use of statistical methods to meet the ultimate goal of ongoing supply of safe and efficacious products that meet patient needs. However, benefits of these methods extend beyond only compliance. Statistical thinking and application provide substantial business and patient benefit as they provide robust evidence of product and process understanding, acceptable risk and adequate process performance. In this 3-day course, examples will be presented for the statistical methods commonly leveraged for CMC submissions to define sampling and acceptance criteria (multiple applications), inform the process definition and control strategy, manage patient risk, and assure ongoing product quality.

  • Integrating data analytics to accelerate development, improve processes and reduce risk
  • Design of Experiments to enable Quality by Design and determine the optimal control strategy
  • Sampling and acceptance criteria: Establishing Specifications; Comparability; Homogeneity; Process Validation/PPQ
  • Stability monitoring and shelf life
  • Data visualization
  • Ensuring ongoing quality
  • Common pitfalls
  • The most common and powerful statistical methods used across the CMC spectrum of activities
  • The relationship of statistical methods and Quality Risk Management (QRM)
  • Key reasons to use Design of Experiments
    (DOE) for process development
  • Understanding the components of a statistical
    sampling plan and statistical intervals
  • Leveraging science, patient needs and statistics to establish specifications
  • Robust methods for comparability and homogeneity
  • Connecting stability trends, shelf life and release specifications
  • Elements and nuances of an Ongoing Process Verification (OPV) Program
  • The powerful combination of your eyes, your knowledge, and a “good” graph

CMC Statistics

November 4 - 6, 2024, Live Online Training
Regular price $2,250
Unit price
per 
Tara Scherder

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.

START TIMES

11:00 AM New York time

8:00 AM Los Angeles time

4:00 PM London time

5:00 PM Vienna time

Group discounts available upon request - contact us.

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Course Description

Multiple ICH and regulatory agency guidelines applicable to CMC activities explicitly cite the use of statistical methods to meet the ultimate goal of ongoing supply of safe and efficacious products that meet patient needs. However, benefits of these methods extend beyond only compliance. Statistical thinking and application provide substantial business and patient benefit as they provide robust evidence of product and process understanding, acceptable risk and adequate process performance. In this 3-day course, examples will be presented for the statistical methods commonly leveraged for CMC submissions to define sampling and acceptance criteria (multiple applications), inform the process definition and control strategy, manage patient risk, and assure ongoing product quality.

  • Integrating data analytics to accelerate development, improve processes and reduce risk
  • Design of Experiments to enable Quality by Design and determine the optimal control strategy
  • Sampling and acceptance criteria: Establishing Specifications; Comparability; Homogeneity; Process Validation/PPQ
  • Stability monitoring and shelf life
  • Data visualization
  • Ensuring ongoing quality
  • Common pitfalls
  • The most common and powerful statistical methods used across the CMC spectrum of activities
  • The relationship of statistical methods and Quality Risk Management (QRM)
  • Key reasons to use Design of Experiments
    (DOE) for process development
  • Understanding the components of a statistical
    sampling plan and statistical intervals
  • Leveraging science, patient needs and statistics to establish specifications
  • Robust methods for comparability and homogeneity
  • Connecting stability trends, shelf life and release specifications
  • Elements and nuances of an Ongoing Process Verification (OPV) Program
  • The powerful combination of your eyes, your knowledge, and a “good” graph

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

CMC Statistics

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

In-house Training

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