Statistical Considerations for ICH Guidelines: 2-day In-person Seminar
Steven Walfish, President of Statistical Outsourcing Services
Courtyard Marriott Boston, MA
Thursday, August 14, 2014 | Friday, August 15, 2014
The Research Triangle, NC
Thursday, November 6, 2014 | Friday, November 7, 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.
Who will Benefit:
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.
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
This 2 day course will include the following topics:
|Day One (8:30 AM – 4:30 PM)
||Day Two (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
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
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.
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Courtyard Marriott Boston - Cambridge
777 Memorial Drive,
Cambridge, MA 02139, USA
August 14-15, 2014
Special Offer for the attendees of this seminar:
Rooms available at only $199 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
From Manchester-Boston Regional Airport – MHT: 55.1 mile(s) SE
- 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 T F Green Airport – PVD: 62.1 mile(s) NE
- 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.
- 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.
- South Station: 5 mile(s) SE
- B.U. Central (on the Green Line): 0.8 mile(s) SE
- Central Station (on the Red Line): 0.8 mile(s) NE
- 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. ComplianceOnline is not responsible for any inaccuracies in the same.
The Research Triangle, NC (Venue to be announced shortly)
November 6-7, 2014
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.
- 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. ComplianceOnline is very professional in conducting regulatory trainings.
- QC Supervisor, Aurora Pharmaceutical LLC
The seminar was well organized by ComplianceOnline 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
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.
- 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. ComplianceOnline 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 ComplianceOnline.
- 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. ComplianceOnline 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 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.
- 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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Boston, MA, Local Attractions
The Research Triangle, NC, Local Attractions
Boston Public Garden
This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.
Boston Public Library
The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).
Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.
Museum of Fine Arts
Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.
Museum of Science
The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.
This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.
Old North Church
The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.
Morehead Planetarium and Science Center:
Morehead Planetarium and Science Center is one of the oldest and largest planetariums in the United States. Morehead Planetarium and Science Center offers an informal learning environment for science education that serves nearly 170,000 visitors every year. Its programs include summer science camps, science cafes, family science activities and statewide outreach, featuring the DESTINY mobile science lab and PLANETS portable planetarium.
Museum of Life and Science:
The Museum of Life and Science is one of North Carolina’s top attractions. Situated on 84-acres, the interactive science park includes a science center, a butterfly conservatory which is one of the largest in the world and beautifully-landscaped outdoor exhibits which are safe havens for rescued black bears, lemurs, and endangered red wolves. The Museum's Dinosaur Trail takes visitors on a journey through the Late Cretaceous period.
West Point on the Eno:
Located along a two mile stretch on the scenic Eno River, this 388 acre city park offers a variety of recreational activities such as picnicking, hiking, canoeing, and rafting. An amphitheater is also inside the park, as well as many historic buildings such as a reconstructed 1778 working gristmill, the McCown-Mangum House built in the 1880s, the Hugh Manhum Museum of Photography, and a recreation of a 19th century blacksmith shop.
Sarah P. Duke Gardens:
Duke Gardens is recognized as one of the premier public gardens in the United States, renowned for its landscape design and high quality horticulture. Each year, more than 300,000 visitors come to Duke Gardens from all over the world. Of special interest is their 20-acre Culberson Asiatic Arboretum. About 550 species and cultivars of Asian plants present a living example of the close relationship between the flora of the Eastern U.S. and the flora of eastern Asia.
One of the largest pre-Civil War plantations, this historic plantation offers visitors a glimpse into the past, particularly of the African American slaves who worked the plantation. Two beautifully restored historic buildings and an old barn are on site and self guided tours of the extensive grounds are available, as well as an array of learning opportunities.
St. Joseph's AME Church:
One of the first autonomous African-American churches in America, this beautiful church was converted into a performance hall in 2001 and features an 1891 brick sanctuary that includes a stained glass portrait of Washington Duke.