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Subject: Applied Statistics for FDA Process Validation
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 Content preview:  Applied Statistics for FDA Process Validation Your Gateway
    to Regulatory Compliance View Online About Us Webinars($10) Seminars Past
    Seminar Pictures Use MGCP50 Promo Code to GET FLAT 50% OFF on ALL SEMINARS
    - Offer Ends Today 2-day In-person Seminar Applied Statistics for FDA Process
    Validation Click Here for More Details! Overview:In Guidance for Industry
    Process Validation: General Principle and Practices, process validation is
    defined as, ""...the collection and evaluation of data, from the process
   design stage through commercial production.." The guidance further delineates
    the 'process design stage through commercial production' into three distinct
    stages of the product lifecycle: [...] 
 
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=22></td>
                                    <td width=3D=22540=22>
                                    <table align=3D=22left=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
=22border-collapse:collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=22=
 width=3D=22540=22><=21-- START OF TEXT-->
                                       <tbody>
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                                             <td align=3D=22left=22 class=
=3D=22center=22 style=3D=22margin: 0;  font-size:13px ; color:=23677b82; fo=
nt-family: 'PT Sans', Helvetica, Arial, sans-serif; line-height: 23px;mso-l=
ine-height-rule: exactly;=22><span><b>Overview:</b>In Guidance for Industry=
 Process Validation: General Principle and Practices, process validation is=
 defined as, =22=22=2E=2E=2Ethe collection and evaluation of data, from the=
 process design stage through commercial production=2E=2E=22 The guidance f=
urther delineates the 'process design stage through commercial production' =
into three distinct stages of the product lifecycle:<br />
                                             <br />
                                             Stage 1: Process Design: The c=
ommercial manufacturing process is defined during this stage based on knowl=
edge gained through development and scale-up activities=2E<br />
                                             <br />
                                             Stage 2: Process Qualification=
: During this stage, the process design is evaluated to determine if the pr=
ocess is capable of reproducible commercial manufacturing=2E<br />
                                             <br />
                                             Stage 3: Continued Process Ver=
ification: Ongoing assurance is gained during routine production that the p=
rocess remains in a state of control=2E<a href=3D=22http://seminar=2Eglobal=
compliancepanel=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGzbFCzgf9TUW1NURp=
GdtWzgJC1ezaswBjWJthOHzcrXWLI4ErhNizdzddzazcm5ORHIWVXtpKX%3DWYYCT&amp;_ei_=
=3DEq2tf9zs59idfPO1Sc_9BbkwfoXCIqZCBXO7T8HvbxNIGHhqcCHjuN309Y6V8OK_2O_bW_0Q=
tdIEXd5f88VC8H0tCM=2E=22 style=3D=22color: =23ED5B34; text-decoration: none=
;=22 target=3D=22_blank=22> Read more=2E=2E</a>=2E</span></td>
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gin: 0; font-size:14px ; color:=23677b82; font-family: 'PT Sans', Helvetica=
, Arial, sans-serif; line-height: 0;=22><span> <img alt=3D=22divider image=
=22 border=3D=220=22 class=3D=22divider=22 height=3D=228=22 src=3D=22http:/=
/www=2Eglobalcompliancepanel=2Ecom/images/email-img/divider-image=2Epng=22 =
style=3D=22display: inline-block;=22 width=3D=22113=22 /> </span></td>
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ding=3D=220=22 cellspacing=3D=220=22 class=3D=22table_scale=22 width=3D=226=
00=22>
                     <tbody>
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                           <td width=3D=22100%=22>
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llspacing=3D=220=22 width=3D=22600=22>
                              <tbody>
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                                    <td class=3D=22spacer=22 width=3D=2230=
=22></td>
                                    <td valign=3D=22top=22 width=3D=22540=
=22><=21-- START OF LEFT COLUMN-->
                                    <table align=3D=22left=22 border=3D=220=
=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
=22border-collapse:collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=22=
 width=3D=22230=22><=21-- START OF HEADING-->
                                       <tbody>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-bottom: 5px; border-bottom: 1px solid =
=23f5f6f6; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=235=
05050; font-size:24px; line-height:34px; mso-line-height-rule: exactly;=22>=
<span> Date & Time </span></td>
                                          </tr>
                                          <=21-- END OF HEADING--><=21-- ST=
ART OF TEXT-->
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-top: 10px; margin: 0;  font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; line=
-height: 23px;mso-line-height-rule: exactly;=22><span> <strong>Date:</stron=
g> May 17th & 18th, 2018<br />
                                             <strong>Time:</strong> 9:00 AM=
 to 6:00 PM</span></td>
                                          </tr>
                                          <=21-- END OF TEXT--><=21-- START=
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                                                      <td align=3D=22center=
=22 bgcolor=3D=22=23f5f6f6=22 style=3D=22border-left: 5px solid =23ED5B34; =
padding: 7px 20px;font-size: 13px; line-height: 18px; font-family: 'PT Sans=
', Helvetica, Arial, sans-serif; color:=23677b82; margin: 0 =21important; =
=22 valign=3D=22middle=22><a href=3D=22http://seminar=2Eglobalcompliancepan=
el=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGzbFCzgf9TUW1NURpGdtWzgJC1ezas=
wBjWJthOHzcrXWLI4ErhNizdzddzazcm5ORHIWVXtpKX%3DWYART&amp;_ei_=3DEq2tf9zs59i=
dfPO1Sc_9BbkwfoXCIqZCBXO7T8HvbxNIGHhqcCHjuN309Y6V8OK_2O_bW_0QtdIEXd5f88VC8H=
0tCM=2E=22 style=3D=22 font-style: normal; color:=23677b82;=22 target=3D=22=
_blank=22>Download Seminar Brochure </a></td>
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T OF SPACER-->

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=22 cellpadding=3D=220=22 cellspacing=3D=220=22 style=3D=22border-collapse:=
collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=22 width=3D=2210=22>
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                                    <table align=3D=22right=22 border=3D=22=
0=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=
=3D=22border-collapse:collapse; mso-table-lspace:0pt; mso-table-rspace:0pt;=
=22 width=3D=22280=22>
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-bottom: 5px; border-bottom: 1px solid =
=23f5f6f6; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=235=
05050; font-size:24px; line-height:34px; mso-line-height-rule: exactly;=22>=
<span> Venue</span></td>
                                          </tr>
                                          <=21-- END OF HEADING--><=21-- ST=
ART OF TEXT-->
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22padding-top: 10px; margin: 0;  font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; line=
-height: 23px;mso-line-height-rule: exactly;=22><span> Philadelphia, PA<br =
/>
                                             DoubleTree by Hilton Philadelp=
hia Airport </span></td>
                                          </tr>
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=22 bgcolor=3D=22=23f5f6f6=22 style=3D=22border-left: 5px solid =23ED5B34; =
padding: 7px 20px;font-size: 13px; line-height: 18px; font-family: 'PT Sans=
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el=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGzbFCzgf9TUW1NURpGdtWzgJC1ezas=
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t-family: 'PT Sans', Helvetica, Arial, sans-serif; line-height: 23px;=22><s=
pan> <a href=3D=22http://seminar=2Eglobalcompliancepanel=2Ecom/pub/cc?_ri_=
=3DX0Gzc2X%3DYQpglLjHJlTQGzbFCzgf9TUW1NURpGdtWzgJC1ezaswBjWJthOHzcrXWLI4Erh=
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T OF SPACER-->

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RIGHT COLUMN-->

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0=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=
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=22 width=3D=22420=22><=21-- START OF HEADING-->
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                                             <td align=3D=22left=22 class=
=3D=22center=22 style=3D=22padding-bottom: 5px; border-bottom: 1px solid =
=23f5f6f6; font-family: 'PT Sans', Helvetica, Arial, sans-serif; color:=235=
05050; font-size:22px; line-height:24px; mso-line-height-rule: exactly;=22>=
<span>Heath Rushing </span><br />
                                             <span style=3D=22 color:=23ED5=
B34; font-size:11px;=22><b>Co-founder and Principal, Adsurgo </b></span></t=
d>
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                                          <=21-- END OF HEADING--><=21-- ST=
ART OF TEXT-->
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                                             <td align=3D=22left=22 class=
=3D=22center=22 style=3D=22padding-top: 10px; margin: 0;  font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; line=
-height: 20px;mso-line-height-rule: exactly;=22><span> <strong>Heath Rushin=
g</strong>, is the cofounder of <b>Adsurgo</b> and author of the book Desig=
n and Analysis of Experiments by Douglas Montgomery: A Supplement for using=
 JMP=2E Previously, he was the JMP and Six Sigma training manager at SAS=2E=
 He led a team of nine technical professionals designing and delivering app=
lied statistics and quality continuing education courses=2E </span></td>
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color:=23ffffff; margin: 0 =21important; =22 valign=3D=22middle=22><a href=
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=22 cellpadding=3D=220=22 cellspacing=3D=220=22 class=3D=22full=22 style=3D=
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22 width=3D=22540=22><strong>GlobalComp=
liancePanel </strong></td>
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><span>161 Mission Falls Lane, Suite =
216, Fremont, CA 94539, USA=2E </span></td>
                                          </tr>
                                          <tr>
                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><strong>Phone:</strong> +1-800-447-9=
407</td>
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=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><strong>Fax: </strong> 302 288 6884<=
/td>
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                                             <td align=3D=22center=22 class=
=3D=22center=22 style=3D=22margin: 0; padding-bottom:30px;font-size:13px ; =
color:=23677b82; font-family: 'PT Sans', Helvetica, Arial, sans-serif; padd=
ing-bottom:10px; line-height: 18px;=22><a href=3D=22http://seminar=2Eglobal=
compliancepanel=2Ecom/pub/cc?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGzbFCzgf9TUW1NURp=
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r=2Eglobalcompliancepanel=2Ecom/pub/optout?_ri_=3DX0Gzc2X%3DYQpglLjHJlTQGzb=
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