BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T155717Z UID:4bbdf607-345e-4263-a20e-7497c0d82070 DTSTART:20211105T100000 DTEND:20211106T100000 CLASS:PRIVATE DESCRIPTION:
Throughout 21 CFR and guidance documents for the pharmaceuti cal\, biopharmaceutical\, and medical device industries\, the application of statistical methods are specified for: setting validation criteria and specifications\, performing measurement systems analysis (MSA)\, conductin g stability analysis\, using design of experiment (DOE) for process develo pment and validation\, developing process control charts\, and determining process capability indices.
\n\nDifferent statistical methods are r equired for each of these particular applications. Data and tolerance inte rvals are common tools used for setting acceptance criteria and specificat ions. Simple linear regression and analysis-of-covariance (ANCOVA) are use d for setting expiries and conducting stability analysis studies. Two-samp le hypothesis tests\, analysis-of-variance (ANOVA)\, regression\, and ANCO VA are methods used for analyzing designed experiment for process developm ent and validation studies. Descriptive statistics (distribution\, summary statistics)\, run charts\, and probability (distributions) are used for d eveloping process control charts and developing process capability indices .
\n\nThis course provides instruction on how to apply the appropria te statistical approaches: descriptive statistics\, data intervals\, hypot hesis testing\, ANOVA\, regression\, ANCOVA\, and model building. Once com petence in each of these areas is established\, industry-specific applicat ions are presented for the participants.
\n\n21 CFR and guidance documents for the pharmaceutical\, biopharmaceutical\, and medical device industries specify the application of statistical methods across the product quality lifecycle.
\n\nAc cording to the Quality System Regulation (QSR) for medical devices\, " \;Where appropriate\, each manufacturer shall establish and maintain proce dures for identifying valid statistical techniques required for establishi ng\, controlling\, verifying the acceptability of process capability and p roduct characteristics."\; Although there are many statistical method that may be applied to satisfy this portion of the QSR\, there are some co mmonly accepted methods that all companies can and should be using to deve lop acceptance criteria\, to ensure accurate and precise measurement syste ms\, to fully characterize manufacturing processes\, to monitor and contro l process results and to select an appropriate number of samples.
\n\n< p>According to both 21 CFR and guidance documents\, the need for statistic al methods is well established from discovery through product discontinuat ion. 21 CFR specifies the "\;the application of suitable statistical p rocedures"\; to establish both in-process and final specifications. Th e guidance documents necessitate the application of statistical methods fo r development and validation of measurement systems\, process understandin g using Quality by Design (QbD) principles\, process validation\, as well as ensuring the manufacturing process is in control and is capable.\n\ nThis course provides instruction statistical methods for data analysis of applications related to the pharmaceutical\, biopharmaceutical\, and m edical device industries.
\n\nThis seminar is designed for pharmaceutical\, biop harmaceutical\, and medical device professionals who are involved with pro duct and/or process design:
\n\nLecture 1:
\nBasic Statistics\n\nLecture 2:
\ nIntervals\n\nLecture 3:
\nHypothesis Testing\n\nLecture 4:
\nANOVA\n\nLecture 1:
\nLecture 2:< /p>\nApplied Statistics\n\n
Jim Wisnow
ski \;is the cofounder of Adsurgo LLC and co-author of the bo
ok Design and Analysis of Experiments by Douglas Montgomery: A Supplement
for using JMP. He has over 25 years of experience and currently provides t
raining and consulting services to industry and government in Design of Ex
periments (DOE)\, Reliability Engineering\, Data Visualization\, Predictiv
e Analytics\, and Text Mining. Dr. Wisnowski has been an invited speaker o
n applicability of statistics for national and international conferences.
Prior to his current position\, he was a senior program manager for URS\,
Chief of the Statistics Division in the Mathematics Department at the Air
Force Academy\, and a retired military officer. He is currently a member o
f the editorial board of Quality Engineering and has published numerous in
ternational refereed journal articles on statistics. Jim has a PhD in Indu
strial Engineering from Arizona State University.
\n
\nPlease co
ntact Marilyn Turner: Phone: +1 929 900 1853  \;Email: marilyn.turner
[a] nyeventslist.com for registrations