[Openflow-dev] Know how to go about writing SOP for FDA Inspections

[Sarah G. <web...@in...>]

<p><span style="font-family: verdana, geneva; font-size: x-small;">Dear Colleague,</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">Amidst the deadlines, the endless emails, the frantic race to the meeting, you tend to keep off the vital training required for your improvement. It's time to become more effective.</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist? Who should security/receptionist call when FDA arrives unannounced at your firm? That’s right, FDA does not schedule an inspection – they just show up, present their credentials and state we’re here for an inspection.</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">Don’t panic! Be prepared! Know how to go about writing SOP for FDA Inspections. Make sure your people are adequately trained on this SOP document, when two, three or four FDA Investigators surprise you.</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">If you want to make sure your Master Production and Batch Production Records are organized and ready for review and whether your stability studies are organized and prepared for scrutiny by FDA, then join us for this interactive session.</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;"><span style="font-size: small;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hfPi0Ce4FG0INi0p37g0Eu"><b><i>Are you ready for the next FDA inspection? Inspection Readiness preparation</i></b></a></span><b><i></i></b></span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">Date: September 15, 2016</span><br><span style="font-family: verdana, geneva; font-size: x-small;"> Time: 1:00pm - 2:00pm EDT US</span><br><span style="font-family: verdana, geneva; font-size: x-small;"> Duration: 60 Minutes</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hfPi0Ce4FG0INi0p37i0Ew">Register Now</a></span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;"><b>Course Description:<br> </b>This course will enable you to be more successful and have better teamwork during inspections by knowing the do’s and don’ts before you make any serious errors and improve your preparedness to help your continuous quality improvement initiatives.</span></p>
<ul>
<li><span style="font-family: verdana, geneva; font-size: x-small;">Know how to write standard operating procedure for FDA Inspections</span></li>
<li><span style="font-family: verdana, geneva; font-size: x-small;">Know what things need to be done to ensure you are ready for FDA Surprise Inspections and other regulatory inspections</span></li>
<li><span style="font-family: verdana, geneva; font-size: x-small;">Acquire the knowledge on how to behave during these inspections – how to answer their questions, what not to say and where you should have FDA stay while they are on-site</span></li>
</ul>
<p><span style="font-family: verdana, geneva; font-size: x-small;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hfPi0Ce4FG0INi0p37i0Ew">Register Now</a></span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;"><b>Your Expert Instructor:<br> Brian G. Nadel </b>is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Process Validation and Inspection Readiness.<a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hfPi0Ce4FG0INi0p37j0Ex">Read more</a></span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">Thank you and look forward to having you with us.</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;">Best,</span></p>
<p><span style="font-family: verdana, geneva; font-size: x-small;"><strong>Sarah George</strong><b><br> </b>Senior Training Consultant</span><br><span style="font-family: verdana, geneva; font-size: x-small;"> Compliance Global Inc.</span><br><span style="font-family: verdana, geneva; font-size: x-small;"> Toll Free: +1-844-746-4244</span></p>
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