skilltrainee.com Open in urlscan Pro
108.167.172.187 Public Scan

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Submitted URL:
http://click.activealliancee.com/?qs=950fb17edccfc10f6fabaf377a8333e0577a87b68aabbb9058aeaa78cd64be7a8c24bfe2696dc885e940daeb1055...
Effective URL:
https://skilltrainee.com/conference/riskbased-approach-to-validating-it-infrastructure-used-for-fdaregulated-systems
Submission: On May 08 via api (May 8th 2024, 1:16:16 pm UTC) from DE — Scanned from DE

Form analysis
6 forms found in the DOM

POST conference

<form action="conference" method="post"> &nbsp; <i class="ace-icon fa fa-search nav-search-icon"></i>
  <input type="text" name="search" value="" placeholder="Enter Keyword">
</form>

POST cart.php

<form action="cart.php" method="post" style="    margin-top: 10px;
">
  <input type="hidden" name="track" value="||">
  <div class="thumbnail training_option" style="overflow:hidden;text-align:left;"> <!--<div class="alert alert-danger training_msg" id="err_exsts">-->
    <!--    <button type="button" class="close" data-dismiss="alert"><i class="ace-icon fa fa-times"></i></button>-->
    <!--    <strong><i class="ace-icon fa fa-times"></i> Error </strong>Conference Exists In Wish-list.-->
    <!--</div>-->
    <!--<div class="alert alert-block alert-success training_msg" id="succ_wish" >-->
    <!--    <button type="button" class="close" data-dismiss="alert">-->
    <!--        <i class="ace-icon fa fa-times"></i>-->
    <!--    </button>-->
    <!--    <p><strong><i class="ace-icon fa fa-check"></i> Congrats </strong> Conference Added In Wish-list.</p>-->
    <!--</div>-->
    <div class="pricePanel">
      <h4 data-toggle="tooltip" data-placement="top" title="" data-original-title="Product ID# 2378">Training Price <br> <span class="pricePanelPrice" style="display:none;text-align:center" id="sum"> </span></h4>
      <div style="display:block;positosition:static; padding:10px 0px; ">
        <div style="width:90%; float:left;  display:block;"> Recording &nbsp; &nbsp; <span class="training_rs">$249</span>
        </div>
        <div style="width:5%; float:right; border:0px solid blue; display:block;"><input class="add_price" type="checkbox" title="249" name="options[]" value="TVRRMw==|TVRVPQ=="></div>
      </div>
      <div style="display:block;positosition:static; padding:10px 0px; ">
        <div style="width:90%; float:left;  display:block;"> Digital Download &nbsp; &nbsp; <span class="training_rs">$299</span>
        </div>
        <div style="width:5%; float:right; border:0px solid blue; display:block;"><input class="add_price" type="checkbox" title="299" name="options[]" value="TVRRMw==|TVRZPQ=="></div>
      </div>
      <div style="display:block;positosition:static; padding:10px 0px; ">
        <div style="width:90%; float:left;  display:block;"> Transcript (PDF) &nbsp; &nbsp; <span class="training_rs">$249</span>
        </div>
        <div style="width:5%; float:right; border:0px solid blue; display:block;"><input class="add_price" type="checkbox" title="249" name="options[]" value="TVRRMw==|TWpZPQ=="></div>
      </div><br><br>
      <button type="submit" style="background-color: #365d86;font-family: 'Raleway', sans-serif; float:right" class="btn btn-form" name="add_to_cart">Add to cart</button>
    </div>
  </div>
</form>

POST unsubscribe.php

<form action="unsubscribe.php" method="post" role="form" id="unsubscribe_form" class="contactForm">
  <!--<p class="loading" style="text-align:center; display:none;"><img src="img/Loading_icon.gif" style="width:60px;" /></p>-->
  <div class="form-group">
    <input type="email" required="" class="form-control br-radius-zero" name="unsubscribe_email" id="email" placeholder="Your Email Id">
  </div>
  <div class="form-group">
    <p>Enter Capcha Here </p>
    <input type="text" name="captcha" placeholder="enter capcha" class="form-control">
    <p>
    </p>
    <h3>3LEwg9</h3>
    <p></p>
    <input type="hidden" name="cap" value="3LEwg9">
    <!--<p>Can't read the image? <a href='javascript: refreshCaptcha();'>click here</a> to refresh</p>-->
  </div>
</form>

Name: speaker — POST

<form action="" method="POST" name="speaker">
  <!--<form name="speaker" >-->
  <h4 style="text-align:center;font-size:22px;">Speaker Opportunity</h4>
  <div class="panel-body form-horizontal payment-form">
    <div class="form-group">
      <label class="col-sm-3 control-label">First Name <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input required="" type="text" class="form-control" name="firstname" value="">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Last Name <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input required="" type="text" class="form-control" name="lastname" value="">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Job Title <span style="color:#ff0000"></span></label>
      <div class="col-sm-9">
        <input type="text" class="form-control" name="jobtitle" value="">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Company</label>
      <div class="col-sm-9">
        <input type="text" class="form-control" name="company" value="">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Phone <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input type="text" name="phone" value="" size="15" class="form-control" oninput="this.value = this.value.replace(/[^0-9.]/g, '').replace(/(\..*?)\..*/g, '$1').replace(/^0[^.]/, '0');">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Fax</label>
      <div class="col-sm-9">
        <input type="text" class="form-control" name="fax" value="" onkeypress="return acceptOnlyNumber(event);">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Email <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input required="" type="text" class="form-control" name="email" value="">
      </div>
    </div>
    <!--<div class="form-group">
					<label class="col-sm-3 control-label">Website</label>
					<div class="col-sm-9">
						<input type="text" class="form-control" name="website" value="">
					</div>
				</div>-->
    <div class="form-group">
      <label class="col-sm-3 control-label">Industries <span style="color:#ff0000"></span></label>
      <div class="col-sm-9">
        <textarea class="form-control" type="text" name="industries" cols="30" rows="2"></textarea>
      </div>
    </div>
    <!--<div class="form-group">
					<label class="col-sm-3 control-label">Role <span style="color:#ff0000"></span></label>
					<div class="col-sm-9">
						<textarea class="form-control" type="text" name="roles" cols="30" rows="2"></textarea>
					</div>
				</div>
				
				<div class="form-group">
					<label class="col-sm-3 control-label">Years of experience <span style="color:#ff0000"></span></label>
					<div class="col-sm-9">
						<select name="experience" class="form-control">
							<option value="4-7">4-7</option>
							<option value="8-10">8-10</option>
							<option value="10-12">10-12</option>
							<option value="12-15">12-15</option>
							<option value="15+">15+</option>
						</select>
					</div>
				</div>
				
				<!--<div class="form-group">
					<label class="col-sm-3 control-label">Please include <br>information on any <br>articles published and <br>speaking engagements.<span style="color:#ff0000"></span></label>
					<div class="col-sm-9">
						<textarea class="form-control" type="hidden" name="articlespublished" cols="30" rows="2">null</textarea>
					</div>
				</div>
				
				<div class="form-group">
					<label class="col-sm-3 control-label">Topic/subject you would<br>like to speak on. <span style="color:#ff0000">*</span></label>
					<div class="col-sm-9">
						<textarea class="form-control" type="hidden" name="proposed_training_topics" cols="30" rows="2">null</textarea>
					</div>
				</div>
				
				<div class="form-group">
					<label class="col-sm-3 control-label">Brief Profile <span style="color:#ff0000"></span></label>
					<div class="col-sm-9">
						<textarea class="form-control" type="text" name="briefprofile" cols="30" rows="2"></textarea>
					</div>
				</div>
				
				 -->
    <div class="form-group">
      <label class="col-sm-3 control-label">Enter Capcha<span style="color:#ff0000"></span></label>
      <div class="col-sm-9">
        <input type="text" name="captcha" class="form-control">
        <p>
        </p>
        <h3>Y1Eu4p</h3>
        <p></p>
        <input type="hidden" name="cap" value="Y1Eu4p">
        <!--<p>Can't read the image? <a href='javascript: refreshCaptcha();'>click here</a> to refresh</p>-->
      </div>
    </div>
    <div id="CreateAccountTextDiv" class="pull-right">
      <input type="submit" class="btn btn-success" value="Register" name="speakerregister">
    </div>
  </div>
</form>

Name: suggest — POST

<form action="" method="POST" name="suggest" onsubmit="return validateSubscribeForm(this);">
  <!--<form name="suggest" onsubmit="return validateSubscribeForm(this);">-->
  <h4 style="text-align:center;font-size:22px;">Suggest a Topic</h4>
  <div class="panel-body form-horizontal payment-form">
    <div class="form-group">
      <label class="col-sm-3 control-label">Name <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input required="" type="text" class="form-control" name="name" value="">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Email Address <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input required="" type="email" class="form-control" name="email" value="">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Phone <span style="color:#ff0000">*</span></label>
      <div class="col-sm-9">
        <input required="" class="form-control" type="text" name="phone" value="" oninput="this.value = this.value.replace(/[^0-9.]/g, '').replace(/(\..*?)\..*/g, '$1').replace(/^0[^.]/, '0');">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Job Title</label>
      <div class="col-sm-9">
        <input type="text" class="form-control" name="job_title">
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Industry<span style="color:#ff0000"></span></label>
      <div class="col-sm-9">
        <textarea class="form-control" name="Industry" cols="40" rows="3"></textarea>
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Topic Suggestion <span style="color:#ff0000"></span></label>
      <div class="col-sm-9">
        <textarea class="form-control" name="topic_suggestion" cols="40" rows="3"></textarea>
      </div>
    </div>
    <div class="form-group">
      <label class="col-sm-3 control-label">Enter Capcha<span style="color:#ff0000"></span></label>
      <div class="col-sm-9">
        <input type="text" name="captcha" class="form-control">
        <p>
        </p>
        <h3>nZ6QWu</h3>
        <p></p>
        <input type="hidden" name="cap" value="nZ6QWu">
        <!--<p>Can't read the image? <a href='javascript: refreshCaptcha();'>click here</a> to refresh</p>-->
      </div>
    </div>
    <!--<div class="form-group">
					<label class="col-sm-3 control-label">Primary Area Of Interest</label>
					<div class="col-sm-9">
						<input type="text" class="form-control" name="area_of_interest" value="">
					</div>
				</div>-->
    <input style="float:right;" type="submit" class="btn btn-success" name="subscribe">
  </div>
</form>

Name: subscribeform — POST

<form action="" method="POST" name="subscribeform" onsubmit="return validateSubscribeForm(this);">
  <!--<form name="subscribeform" onsubmit="return validateSubscribeForm(this);">-->
  <h4 style="text-align:center;font-size:22px;">Subscribe Upcoming Updates</h4>
  <table cellspacing="0" cellpadding="0" border="0" width="100%" style="border:none;">
    <tbody>
      <tr>
        <td width="100%" style="border:none;">
          <div class="panel-body form-horizontal payment-form">
            <div class="form-group">
              <label class="col-sm-3 control-label">Name <span style="color:#ff0000">*</span></label>
              <div class="col-sm-9">
                <input required="" type="text" class="form-control" name="name" value="">
              </div>
            </div>
            <div class="form-group">
              <label required="" class="col-sm-3 control-label">Email <span style="color:#ff0000">*</span></label>
              <div class="col-sm-9">
                <input class="form-control" type="text" name="email" value="">
              </div>
            </div>
            <div class="form-group">
              <label required="" class="col-sm-3 control-label">Phone <span style="color:#ff0000">*</span></label>
              <div class="col-sm-9">
                <input class="form-control" type="text" name="phone" value="" oninput="this.value = this.value.replace(/[^0-9.]/g, '').replace(/(\..*?)\..*/g, '$1').replace(/^0[^.]/, '0');">
              </div>
            </div>
            <div class="form-group">
              <label class="col-sm-3 control-label">Job Title <span style="color:#ff0000"></span></label>
              <div class="col-sm-9">
                <input type="text" class="form-control" name="jobtitle" value="">
              </div>
            </div>
            <div class="form-group">
              <label class="col-sm-3 control-label">Your Industry <span style="color:#ff0000"></span></label>
              <div class="col-sm-9">
                <input class="form-control" type="text" name="industry">
              </div>
            </div>
            <div class="form-group">
              <label class="col-sm-3 control-label">Country </label>
              <div class="col-sm-9">
                <select class="form-control" name="country">
                  <option value="">--Choose Country--</option>
                  <!-- Begin Screen component://common/widget/CommonScreens.xml#countries -->
                  <!-- Begin Template component://common/webcommon/includes/countries.ftl -->
                  <option value="">Choose Country</option>
                  <option value="USA">United States</option>
                  <option value="AFG">Afghanistan</option>
                  <option value="ALB">Albania</option>
                  <option value="DZA">Algeria</option>
                  <option value="ASM">American Samoa</option>
                  <option value="AND">Andorra</option>
                  <option value="AGO">Angola</option>
                  <option value="AIA">Anguilla</option>
                  <option value="ATA">Antarctica</option>
                  <option value="ATG">Antigua And Barbuda</option>
                  <option value="ARG">Argentina</option>
                  <option value="ARM">Armenia</option>
                  <option value="ABW">Aruba</option>
                  <option value="AUS">Australia</option>
                  <option value="AUT">Austria</option>
                  <option value="AZE">Azerbaijan</option>
                  <option value="BHS">Bahamas</option>
                  <option value="BHR">Bahrain</option>
                  <option value="BGD">Bangladesh</option>
                  <option value="BRB">Barbados</option>
                  <option value="BLR">Belarus</option>
                  <option value="BEL">Belgium</option>
                  <option value="BLZ">Belize</option>
                  <option value="BEN">Benin</option>
                  <option value="BMU">Bermuda</option>
                  <option value="BTN">Bhutan</option>
                  <option value="BOL">Bolivia</option>
                  <option value="BIH">Bosnia And Herzegowina</option>
                  <option value="BWA">Botswana </option>
                  <option value="BVT">Bouvet Island</option>
                  <option value="BRA">Brazil</option>
                  <option value="IOT">British Indian Ocean Territory</option>
                  <option value="BRN">Brunei Darussalam</option>
                  <option value="BGR">Bulgaria</option>
                  <option value="BFA">Burkina Faso</option>
                  <option value="BDI">Burundi</option>
                  <option value="KHM">Cambodia</option>
                  <option value="CMR">Cameroon</option>
                  <option value="CAN">Canada</option>
                  <option value="CPV">Cape Verde</option>
                  <option value="CYM">Cayman Islands</option>
                  <option value="CAF">Central African Republic</option>
                  <option value="TCD">Chad</option>
                  <option value="CHL">Chile</option>
                  <option value="CHN">China</option>
                  <option value="CXR">Christmas Island</option>
                  <option value="CCK">Cocos (keeling) Islands</option>
                  <option value="COL">Colombia</option>
                  <option value="COM">Comoros</option>
                  <option value="COG">Congo</option>
                  <option value="COD">Congo, The Democratic Republic Of The</option>
                  <option value="COK">Cook Islands</option>
                  <option value="CRI">Costa Rica</option>
                  <option value="CIV">Cote D'ivoire</option>
                  <option value="HRV">Croatia (local Name: Hrvatska)</option>
                  <option value="CUB">Cuba</option>
                  <option value="CYP">Cyprus</option>
                  <option value="CZE">Czech Republic</option>
                  <option value="DNK">Denmark</option>
                  <option value="DJI">Djibouti</option>
                  <option value="DMA">Dominica</option>
                  <option value="DOM">Dominican Republic</option>
                  <option value="TLS">East Timor</option>
                  <option value="ECU">Ecuador</option>
                  <option value="EGY">Egypt</option>
                  <option value="SLV">El Salvador</option>
                  <option value="ENGL">ENGL</option>
                  <option value="GNQ">Equatorial Guinea</option>
                  <option value="ERI">Eritrea</option>
                  <option value="EST">Estonia</option>
                  <option value="ETH">Ethiopia</option>
                  <option value="FLK">Falkland Islands (malvinas)</option>
                  <option value="FRO">Faroe Islands</option>
                  <option value="FJI">Fiji</option>
                  <option value="FIN">Finland</option>
                  <option value="FRA">France</option>
                  <option value="FXX">France, Metropolitan</option>
                  <option value="GUF">French Guiana</option>
                  <option value="PYF">French Polynesia</option>
                  <option value="ATF">French Southern Territories</option>
                  <option value="GAB">Gabon</option>
                  <option value="GMB">Gambia</option>
                  <option value="GEO">Georgia</option>
                  <option value="DEU">Germany</option>
                  <option value="GHA">Ghana</option>
                  <option value="GIB">Gibraltar</option>
                  <option value="GRC">Greece</option>
                  <option value="GRL">Greenland</option>
                  <option value="GRD">Grenada</option>
                  <option value="GLP">Guadeloupe</option>
                  <option value="GUM">Guam</option>
                  <option value="GTM">Guatemala</option>
                  <option value="GIN">Guinea</option>
                  <option value="GNB">Guinea-bissau</option>
                  <option value="GUY">Guyana</option>
                  <option value="HTI">Haiti</option>
                  <option value="HMD">Heard And Mc Donald Islands</option>
                  <option value="VAT">Holy See (vatican City State)</option>
                  <option value="HND">Honduras</option>
                  <option value="HKG">Hong Kong</option>
                  <option value="HUN">Hungary</option>
                  <option value="ISL">Iceland</option>
                  <option value="IND">India</option>
                  <option value="IDN">Indonesia</option>
                  <option value="IRN">Iran (islamic Republic Of)</option>
                  <option value="IRQ">Iraq</option>
                  <option value="IRL">Ireland</option>
                  <option value="ISR">Israel</option>
                  <option value="ITA">Italy</option>
                  <option value="JAM">Jamaica</option>
                  <option value="JPN">Japan</option>
                  <option value="JOR">Jordan</option>
                  <option value="KAZ">Kazakhstan</option>
                  <option value="KEN">Kenya</option>
                  <option value="KIR">Kiribati</option>
                  <option value="PRK">Korea, Democratic People's Republic Of</option>
                  <option value="KOR">Korea, Republic Of</option>
                  <option value="KWT">Kuwait</option>
                  <option value="KGZ">Kyrgyzstan</option>
                  <option value="LAO">Lao People's Democratic Republic</option>
                  <option value="LVA">Latvia</option>
                  <option value="LBN">Lebanon</option>
                  <option value="LSO">Lesotho</option>
                  <option value="LBR">Liberia</option>
                  <option value="LBY">Libyan Arab Jamahiriya</option>
                  <option value="LIE">Liechtenstein</option>
                  <option value="LTU">Lithuania</option>
                  <option value="LUX">Luxembourg</option>
                  <option value="MAC">Macau</option>
                  <option value="MKD">Macedonia, The Former Yugoslav Republic Of</option>
                  <option value="MDG">Madagascar</option>
                  <option value="MWI">Malawi</option>
                  <option value="MYS">Malaysia</option>
                  <option value="MDV">Maldives</option>
                  <option value="MLI">Mali</option>
                  <option value="MLT">Malta</option>
                  <option value="MHL">Marshall Islands</option>
                  <option value="MTQ">Martinique</option>
                  <option value="MRT">Mauritania</option>
                  <option value="MUS">Mauritius</option>
                  <option value="MYT">Mayotte</option>
                  <option value="MEX">Mexico</option>
                  <option value="FSM">Micronesia, Federated States Of</option>
                  <option value="MDA">Moldova, Republic Of</option>
                  <option value="MCO">Monaco</option>
                  <option value="MNG">Mongolia</option>
                  <option value="MNE">Montenegro</option>
                  <option value="MSR">Montserrat</option>
                  <option value="MAR">Morocco</option>
                  <option value="MOZ">Mozambique</option>
                  <option value="MMR">Myanmar</option>
                  <option value="NIRL">NIRL</option>
                  <option value="NAM">Namibia</option>
                  <option value="NRU">Nauru</option>
                  <option value="NPL">Nepal</option>
                  <option value="NLD">Netherlands</option>
                  <option value="ANT">Netherlands Antilles</option>
                  <option value="NCL">New Caledonia</option>
                  <option value="NZL">New Zealand</option>
                  <option value="NIC">Nicaragua</option>
                  <option value="NER">Niger</option>
                  <option value="NGA">Nigeria</option>
                  <option value="NIU">Niue</option>
                  <option value="NFK">Norfolk Island</option>
                  <option value="MNP">Northern Mariana Islands</option>
                  <option value="NOR">Norway</option>
                  <option value="OMN">Oman</option>
                  <option value="PAK">Pakistan</option>
                  <option value="PLW">Palau</option>
                  <option value="PSE">Palestinian Territory, Occupied</option>
                  <option value="PAN">Panama</option>
                  <option value="PNG">Papua New Guinea</option>
                  <option value="PRY">Paraguay</option>
                  <option value="PER">Peru</option>
                  <option value="PHL">Philippines</option>
                  <option value="PCN">Pitcairn</option>
                  <option value="POL">Poland</option>
                  <option value="PRT">Portugal</option>
                  <option value="PRI">Puerto Rico</option>
                  <option value="QAT">Qatar</option>
                  <option value="REU">Reunion</option>
                  <option value="ROU">Romania</option>
                  <option value="RUS">Russian Federation</option>
                  <option value="RWA">Rwanda</option>
                  <option value="KNA">Saint Kitts And Nevis</option>
                  <option value="LCA">Saint Lucia</option>
                  <option value="VCT">Saint Vincent And The Grenadines</option>
                  <option value="WSM">Samoa</option>
                  <option value="SMR">San Marino</option>
                  <option value="STP">Sao Tome And Principe</option>
                  <option value="SAU">Saudi Arabia</option>
                  <option value="SCOT">Scotland</option>
                  <option value="SEN">Senegal</option>
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RISK-BASED APPROACH TO VALIDATING IT INFRASTRUCTURE USED FOR FDA-REGULATED
SYSTEMS

Recorded Webinar | Carolyn Troiano | All Days

DESCRIPTION


Computer system validation has been regulated by the FDA for more than 30 years,
as it relates to systems used in the manufacturing, testing, and distributing a
product in the pharmaceutical, biotechnology, medical device, or other
FDA-regulated industries.  The FDA requirements ensure thorough planning,
implementation, integration, testing, and management of computer systems that
collect, analyze, and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through
guidelines established by FDA in 1997 and disseminated through 21 CFR Part 11. 
This code describes the basic requirements for validating and documenting ER/ES
capability in systems used in an FDA-regulated environment.

In the early 2000s, the FDA recognized they could not inspect every computer
system at every regulated company and placed the onus on the industry to begin
assessing all regulated computer systems based on risk.  The level of potential
risk, should the system fail to operate correctly, needed to be the basis for
each company’s approach to developing a validation approach and rationale as
part of the planning process.  System size, complexity, business criticality,
GAMP 5 category, and risk rating are the five critical components for
determining the scope and robustness of testing required to ensure data
integrity and product safety.

FDA’s recent focus on data integrity during computer system validation
inspections and audits has brought this issue to the forefront of the importance
of compliance of systems used in regulated industries.  These include all
systems that “touch” products, meaning they are used to create, collect,
analyze, manage, transfer, and report data regulated by FDA.  All structured
data, including databases and unstructured data, including documents,
spreadsheets, presentations, images, audio, and video files, must be managed and
maintained with integrity throughout their life cycle.

We will explore the best practices and strategic approach for evaluating
computer systems used in conducting FDA-regulated activities and determining the
level of potential risk, should they fail, on data integrity, process and
product quality, and consumer/patient safety.  We will walk through the System
Development Life Cycle (SDLC) approach to validation based on risk assessment.
We will also discuss 21 CFR Part 11 and the importance of managing electronic
records and signatures appropriately.

We will cover the approach for validating/qualifying infrastructure components
to FDA-regulated systems, including cloud-based servers and
Software-as-a-Service (SaaS) solutions. A different approach is required for
auditing and performing Installation Qualification (IQ) for systems supported by
these vendors.

We will also walk through the entire set of essential policies and procedures
and other supporting documentation and activities that must be developed and
followed to ensure compliance.  We will provide an overview of practices to
prepare for an FDA inspection. We will also touch on the importance of auditing
computer system hardware, software, tools and utilities, and services vendors.

Finally, we will provide an overview of industry best practices, focusing on
data integrity and risk assessment, that can be leveraged to assist in all your
GxP work.

This webinar benefits the following agencies-

Manufacturing, Testing, Packaging and Distribution companies in the following
industries that are regulated by the FDA are required to follow GDPs:

 * Pharmaceutical
 * Medical Device
 * Biologicals
 * Tobacco
 * E-Liquid/Vapor
 * E-Cigarette
 * Cigar
 * Third-party companies that support those in the above industries, including
   Contract Research Organizations (CROs)
 * Colleges and Universities offering programs of study for Compliance of
   Systems Regulated by FDA

Who should attend?

Personnel in the following roles will benefit:

 * Information Technology (IT) Analysts
 * IT Developers
 * IT Support Staff
 * QC/QA Managers and Analysts
 * Clinical Data Managers and Scientists
 * Compliance Managers and Auditors
 * Lab Managers and Analysts
 * Computer System Validation Specialists
 * GMP Training Specialists
 * Business Stakeholders using Computer Systems regulated by the FDA
 * Regulatory Affairs Personnel
 * Consultants in the Life Sciences and Tobacco Industries
 * Interns working at the companies listed above
 * College students attending schools and studying computer system validation,
   regulatory affairs/matters (related to FDA) or any other discipline that
   involves adherence to FDA regulatory requirements

TRAINING PRICE


Recording     $249

Digital Download     $299

Transcript (PDF)     $249



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