Statistical Considerations for ICH Guidelines: 2-day In-person Seminar
Steven Walfish, President of Statistical Outsourcing Services
Boston, MA| Thursday, October 16, 2014 | Friday, October 17, 2014
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.
This 2 day course will include the following topics:
Meet Your Instructor
Boston, MA (Venue to be announced shortly)
ComplianceOnline 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.
It was very good seminar. I like the interactive discussion between the speaker and participants. Conversations with other participants were very beneficial.
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.
I appreciate ability of presenter to explain material with very clear examples. ComplianceOnline is very professional in conducting regulatory trainings.
The seminar was well organized by ComplianceOnline and the staff was very friendly. Overall it was very good seminar and speaker was very knowledgeable.
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.
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.
Steve was fantastic. Statistical methods to determine and assess process control topic was most valuable to me.
The instructor was very knowledgeable. Loved the event as it was well organized.
The Speaker was very knowledgeable. Overall it was good seminar. It provided a great overview over ICH guidelines.
The seminar was very informative. Interactive discussion was most valuable to me. Got more of the best practices Information.
Very informative and useful. Information I can actually use here at work, Thank You Mr. Walfish!
ComplianceOnline 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.
The program was well organized and coordinated. I like the ICH guidelines, DOE, specifications.
This seminar is good for statisticians. ComplianceOnline is doing well with organizing seminars and webinars.
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.
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 ComplianceOnline.
It was good to see common approaches for specification setting. Good practical feedback as to standard practices and regulatory expectations.
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. ComplianceOnline is a great tool for quality organizations.
I like the Stability statistics session. Very knowledgeable presenter who was willing to listen to attendees expertise.
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 ComplianceOnline.
Good introduction to all areas of ICH and the statistics used with programmatic to implement them at your company. The presenter was very knowledgeable.
The presentation and flow was well organized and related. I like the Tolerance Intervals since they relate to single point measurements.
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.
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