BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T134111Z UID:e00ce7bd-693e-4990-a3b7-1e5cf2f59e95 DTSTART:20210803T090000 DTEND:20210804T090000 CLASS:PRIVATE DESCRIPTION:
Prior to developing a process control plan as part of an ove rall risk management strategy\, process development studies must be comple ted. The objective of these process development studies is to gain knowled ge and understanding about how variation in process parameters explains va riation in the product quality characteristics of the product.
\n\nT he use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine t he functional relationship that links the process parameters to those crit ical quality attributes. Screening designs\, such as 2k factorial and D-op timal designs\, are used to determine critical process parameters. Respons e surface designs\, such as Central Composite Designs (CCDs) and I-optimal designs\, are used to model the functional relationship between those cri tical process parameters and the critical quality attributes.
\n\nTh is course will begin by presenting a primer on statistical analysis\, focu sing on the methods required for analysis of designed experiments. It will then present the steps to DOE\, while demonstrating valuable risk managem ent tools (Ishikawa and FMEA) which can be use pre and post DOE studies. N ext\, participants will learn to generate and analyze multiple screening a nd response surface designs\; the participants will leave with an understa nding of why and how each are used. Then\, the participants will learn how results of the studies can be presented. Lastly\, using the results of th e studies\, the risk management tools will then be updated.
\n\nThe Global Harmonization Task Force (GHTF) Process Validation Guidance for Medical Device Manufacturers provi des guidance on where design of experiments should be applied during proce ss validation\; it suggests the use of both screening and response surface designs during Operational Qualification. In addition\, DOE should be use d during multiple phases of design controls: design and development planni ng\, design verification\, design validation\, design transfer\, and desig n changes.
\n\nIn \;Guidance for Industry Q8 Pharamaceutical Development \;(as well as the annex to Q8)\, suggests applying e xperimental design to demonstrate "\;...an enhanced knowledge of produ ct performance over a range of...process parameters."\; Using this &qu ot\;...enhanced\, quality by design approach..."\; leads to greater sy stem understanding. That greater system understanding has two elements: id entifying critical process parameters and developing a functional relation ship that link those critical process parameters to your critical quality attributes (CQAs). This suggests the use of both screening and response su rface designs during pharmaceutical development studies.
\n\nThe nee d for DOE in product and process development is not only suggested\, but i mperative for both medical device and drug manufactures.
\n\nLecture 1:
\nPrimer on Statisti cal Analysis\n\nL ecture 2:
\nIntroduction to Design of Experiments (DOE)\n\nLecture 3:
\nScreening Designs\n\nLecture 1:
\nScreening Designs (continued)\n\ nLecture 2:
\nResponse Surface Designs\n\nLecture 3:
\ nUtilizing Systematic Understanding from DOE Studies\n\n< ul>\nJi
m Wisnowski \;is the cofounder of Adsurgo LLC and co-author o
f the book Design and Analysis of Experiments by Douglas Montgomery: A Sup
plement for using JMP. He has over 25 years of experience and currently pr
ovides training and consulting services to industry and government in Desi
gn of Experiments (DOE)\, Reliability Engineering\, Data Visualization\, P
redictive Analytics\, and Text Mining. Dr. Wisnowski has been an invited s
peaker on applicability of statistics for national and international confe
rences. Prior to his current position\, he was a senior program manager fo
r 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 of the editorial board of Quality Engineering and has published num
erous international refereed journal articles on statistics. Jim has a PhD
in Industrial Engineering from Arizona State University.
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lease contact Marilyn Turner: Phone: +1 929 900 1853  \;Email: marilyn
.turner [a] nyeventslist.com for registrations