Medical Technology Content, Community & Collaboration
Time: March 2, 2017 at 9am to March 3, 2017 at 6pm
Location: SFO, CA
Street: DoubleTree by Hilton Hotel San Francisco Airport 835 Airport Blvd., Burlingame CA 94010-9949
City/Town: SFO, CA
Website or Map: http://www.globalcompliancepa…
Event Type: compliance, training, and, latest, information
Organized By: John Robinson
Latest Activity: Jan 16
Course "Applied Statistics for Scientists and Engineers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices. Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices. This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications are presented for the participants.
Why should you attend?
21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods across the product quality lifecycle.
According to the Quality System Regulation (QSR) for medical devices, "Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, verifying the acceptability of process capability and product characteristics." Although there are many statistical method that may be applied to satisfy this portion of the QSR, there are some commonly accepted methods that all companies can and should be using to develop acceptance criteria, to ensure accurate and precise measurement systems, to fully characterize manufacturing processes, to monitor and control process results and to select an appropriate number of samples.
Location: SFO, CA Date: March 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Hotel San Francisco Airport
Address: 835 Airport Blvd., Burlingame CA 94010-9949
Price: $1,295.00 (Seminar Fee for One Delegate)
Until January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
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