- Seminar Home
- Agenda
- Pricing
- Venue
- Speaker
- On 24th and 25th May, 2012 in Washington (USA)
About Speaker
Mr. 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.
Who Will Benefit
This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
The employees who will benefit include:
• Development Scientists
• Analytical Method Development
• QA/QC Personnel.
The employees who will benefit include:
• Development Scientists
• Analytical Method Development
• QA/QC Personnel.
Venue
Courtyard Washington,
DC/U.S. Capitol
DC/U.S. Capitol
1325 2nd Street NE - Washington, District Of
Columbia 20002 USA
Columbia 20002 USA
- Day 1 - 24th May 2012
- Day 2 - 25th May 2012
Lecture 1: Introduction and Basic Overview of Common Statistical Tools
- Types of Data
- Continuous Versus Discrete
- Descriptive Versus Inferential
- Data Presentation and Graphics
- Normal Distribution
- Introduction to Hypothesis Testing
- P-Value
- Z-Test
- T-Test
- Chi-Square
- F-Test
- Discuss applicable software packages for use:
- Microsoft Excel - SAS
- Mini-Tab - JMP
- Setting appropriate product specifications
- Determine FDA requirements for OOS results
- Determine how to best investigate OOS results
- Introduction to Interval Estimation
- Confidence Interval
- Tolerance Interval
- Outlier Analysis
- Correlation
- Linear Models
- Residual Analysis
- Lack of Fit
- Hazards of Regression
- Multiple Regression
- Non-linear regression (4-parameter models)
- Analysis of stability data including shelf life estimation
- Design experiments appropriately and effectively
- Ensure that experiments are reproducible
- Improve process capability by reducing variability
- Analysis of variance
Lecture 5: Validate your Testing Methods using Statistics
- Analyze ICH guidelines (Q2A & Q2B)
- Ensure robustness and ruggedness of your method
- Develop protocols based on sound statistical methods
- Quantify validation characteristics:
- -linearity -range
- -accuracy -limit of detection (LOD)
- -precision -limit of quantitation (LOQ)
- Regression analysis and variance components
- Analysis of Stability data.
- Define Statistical Process Control (SPC)
- Determine how SPC can be applied to and help your process
- Identify the benefits of using SPC
- Trend Analysis
- Comply with FDA Requirements for Process Analytical Technology (PAT)
- Define Process analytical technologies and identify related tools
- Identify the role statistics play in the PAT framework
- Comply with the FDA�s 2004 PAT draft guidance requirements
- Process Analytical Technology
- Define different types of sampling
- Random
- Stratified
- Composite
- Create and justify your sampling plan
- Account for sampling and measurement error
- Determine the relationship between sample size, statistical precision, and statistical power
- Examine statistical techniques relevant to APRs
- Use descriptive statistics to present the data
- Use graphs and plots effectively
- Interpret statistical data to identify trends and deviations
Register By
Between February 16th 2012 to April 27th 2012
Between April 28st 2012 to May 23rd 2012
Price
$1495
$1695
Savings
$200
0
- The registration fee includes am/pm breaks & luncheons and seminar fee.
- Group Discounts - 2 or 3 participants get a 10%, Pay for 4 and 5 can attend, Pay for 8 and 10 can attend
- Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link
- Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 1000 N West Street, Suite 1200, Wilmington, DE 19801
- PO: Please drop an email to support@globalcompliancepanel.com or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884
- Wire Transfer: Please drop an email to support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer information
Terms and Conditions:
Seminar Registration is subject to following terms and conditions. If you need any clarification before registering for the seminar please call us @ 1800 447 9407 or email us @ reg@globalcompliancepanel.com
Payment:
Payments to be made at least 2 days prior to the seminar by any of the above mentioned options.
Confirmation:
A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled for the event. Please allow 2 business days for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. Please submit payment for the prevailing rate. Please be advised that if payment or written cancellation notice is not received by 6 business days prior to the seminar start date, your credit card will be charged the prevailing rate.
Attendee substitution:
If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. However, it has to be confirmed in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.
Refund Policy:
A request for refund should be made in writing and faxed to 302 288 6884 or emailed to customersupport@globalcompliancepanel.com latest by 6 business days prior to the seminar start date, to receive a full refund minus $150 administrative fee. After that time, no refunds or credit requests will be approved. On-site registrants will not be guaranteed to receive conference materials until all advanced registered attendees receive them. The refund amount minus the administrative fee will be issued as an online voucher which can be redeemed for the same or any new seminar or webinars within the 12 months of the seminar start date.
Cancellation Policy:
GlobalCompliancePanel reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by GlobalCompliancePanel in writing as soon as possible and will receive a full refund. GlobalCompliancePanel will not be responsible for airfare or any other costs incurred due to cancellation.
For more details, contact GlobalCompliancePanel at support@globalcompliancepanel.com or please call 1800 447 9407.
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By registering for the GlobalCompliancePanel seminar I authorize GlobalCompliancePanel has the right to photograph me and to use the photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release GlobalCompliancePanel from all claims arising out of the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.
Date: 24th and 25th May 2012
from 8 am to 5 pm EDT at Courtyard Washington, DC/U.S. Capitol
from 8 am to 5 pm EDT at Courtyard Washington, DC/U.S. Capitol
Mr. 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.
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.
