Statistical Considerations for ICH Guidelines: 2-day In-person Seminar

By: Steven Walfish, President of Statistical Outsourcing Services
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Course Description:

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.

This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and biotechnology company. 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 the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.

Learning Objectives:

Upon course completion participants will be able to:

  • Perform Regression Analysis.
  • Know the difference between confidence intervals and tolerance intervals.
  • Calculate the appropriate sample size.
  • Calculate the probability of risk.
  • Perform Process Characterization for Design Space.
  • Compare FDA requirements to ICH guidelines.

Who will Benefit:

All Development, Quality and Research Scientists from regulated industries will benefit from this training.

  • Quality Managers
  • Assay Development Scientists
  • Quality Analysts
  • Research Scientists
  • Risk Managers

Course Outline:

This 2 day course will include the following topics:

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

1. Introduction/Fundamentals - Statistics
  • Summary Statistics
  • Graphical Techniques
  • Hypothesis Testing
  • Confidence Intervals and Tolerance Intervals
  • Interactive Discussion/Questions

2. ICH “Q” Series
  • Q1 Stability Testing
  • Q2 Validation of Analytical Procedures
  • Q3 Impurities in New Drug Substances
  • Q5 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human of Animal Origin
  • Q6 Specifications
  • Q7 GMP for API
Day One (8:30 AM – 4:30 PM)
3. Statistical Tools in Action (Workshop)
  • Developing a Risk Management Plan
  • Assay Validation
  • Setting Specifications
  • Q8 Pharmaceutical Development
  • Q9 Quality Risk Management
  • Q10 Pharmaceutical Quality System

4. Integrating Statistics
  • Regression – Q1
  • Design of Experiments and ANOVA – Q8
  • Sample Size – Q6
  • Probability – Q9
  • Interactive Discussion/Questions

Meet Your Instructor

Steven Walfish
Steven Walfish
President, Statistical Outsourcing Services

Steven Walfish , is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry. Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics.

Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.


Courtyard Marriott Boston - Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA

October 16-17, 2014

Special Offer for the attendees of this seminar:

Rooms available at only $209 per night.

Please note: Hotel rooms are limited and based on availability

How to Reach

General Driving Directions:

From Boston Logan International Airport – BOS: 7.3 mile(s) W
  • Exit Airport and take MassPike (I-90) West to Exit 20 (Cambridge)
  • Continue straight and cross bridge
  • Take first right after bridge onto Memorial Drive
  • Hotel is 200 yards ahead on the left.

From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
  • Follow I-293 to I-93S towards Boston
  • Take exit 26B (Storrow Drive West) and continue for 3 miles
  • Bear right at the Central Square/MassPike exit and turn right at the light
  • After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.

From T F Green Airport – PVD: 62.1 mile(s) NE
  • Take I95N to I93N
  • Then, take exit 26 (Storrow Drive West) and follow Storrow Drive
  • Take the Central Square/MassPike exit and turn right at light
  • After crossing the bridge, take first right onto Memorial Drive and Hotel is on the left.

Other Transportation:

Bus Station
  • South Station: 5 mile(s) SE

Subway Station
  • B.U. Central (on the Green Line): 0.8 mile(s) SE
  • Central Station (on the Red Line): 0.8 mile(s) NE

Train Station
  • Back Bay Station (BBY): 3 mile(s) SE
  • South Station (BOS): 5 mile(s) SE
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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GRC Seminars is a great one-shop source for webinars and in-person seminars. It was great seminar. Confidence intervals topic was most valuable to me because I use it within my job and am familiar with it.
Chemist II , Intersect ENT

It was very good seminar. I like the interactive discussion between the speaker and participants. Conversations with other participants were very beneficial.
- Sr. Manager Procurement, MedImmune LLC

The seminar was very informative and useful. It helped confirmed that our statistical analyses on the different processes are accurate. Sample size topic was most valuable to me since it is a constant question in our organization.
- Project Specialist, Pfizer Consumer Healthcare

I appreciate ability of presenter to explain material with very clear examples. GRC Seminars is very professional in conducting regulatory trainings.
- QC Supervisor, Aurora Pharmaceutical LLC

The seminar was well organized by GRC Seminars and the staff was very friendly. Overall it was very good seminar and speaker was very knowledgeable.
- Sr. Program Manager, PharMEDium Services, LLC

I got a lot of information by attending this seminar. The instructor was very knowledgeable. There was good amount of interaction between the speaker and the participants. Analytical test method validation topic was useful for me. This is most applicable to projects at work.
- Quality Engineer, Bard Access Systems

Having just basic knowledge on statistics, this course was very helpful for me in terms of how to apply the tools in my work activities as a formulation Scientist.
- Sr. Development Scientist, GlaxoSmithkline

Steve was fantastic. Statistical methods to determine and assess process control topic was most valuable to me.
- Director Technical Operations, McNeil Consumer Healthcare

The instructor was very knowledgeable. Loved the event as it was well organized.
- Quality Assurance, NewLink Genetics

The Speaker was very knowledgeable. Overall it was good seminar. It provided a great overview over ICH guidelines.
- Research statistician, Abbvie, Inc

The seminar was very informative. Interactive discussion was most valuable to me. Got more of the best practices Information.
- Sr. Quality Engineer, Bard Access Systems

Very informative and useful. Information I can actually use here at work, Thank You Mr. Walfish!
- RABQSA CMS Auditor, Diagnostica Stago, Inc

GRC Seminars always has Conferences available to keep me informed on changes to regulatory guidance. Steven is great presenter. He engage the group to discuss the topics in the presentation.
- Sr. Mfg Manager, FibroGen Inc.

The program was well organized and coordinated. I like the ICH guidelines, DOE, specifications.
- QA Associate, Dr Reddy's Laboratories

This seminar is good for statisticians. GRC Seminars is doing well with organizing seminars and webinars.
- Associate Director, Dr Reddy's Laboratories

Great examples and stories. Steven kept things interesting and relevant. I like the sessions on Q7 - GMP for API and trending of process parameters / control.
- Project Manager, Bayer HealthCare, LLC

I like the concept and use of DOE and specific settings. Good topics covered in this seminar with combined thought process. It was a well organized event by GRC Seminars.
- Head - Development Quality Assurance, Dr Reddy's Laboratories

It was good to see common approaches for specification setting. Good practical feedback as to standard practices and regulatory expectations.
- Senior Engineer II, Shire

The seminar was very good and useful to my area. I like the areas covered on statistical analysis for method validation - Because I am doing lots of validation, method transfer etc. GRC Seminars is a great tool for quality organizations.
- Associate Director, Pfizer

I like the Stability statistics session. Very knowledgeable presenter who was willing to listen to attendees expertise.
- Senior Stability Scientist, Noven Pharmaceuticals

The training covered a large amount of data but moved at a good pace with lots of examples. The venue was very good and seminar was well organized by GRC Seminars.
- Novartis

Good introduction to all areas of ICH and the statistics used with programmatic to implement them at your company. The presenter was very knowledgeable.
- Global Head Stability, GlaxoSmithKline Consumer Health R&D

The presentation and flow was well organized and related. I like the Tolerance Intervals since they relate to single point measurements.
- DPT Labs

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

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