Introduction To Pharmaceutical cGMP Training Course :

<strong>Course Schedule - December 11, 2008 at 11:00 a.m. - 12:30 p.m. (EST) </strong><br/><br/>This 90-minute <b><i>accredited</b></i> training course introduces the employee to the cGMP environment. The attendee will gain understanding of the FDA, the Code of Federal Regulations, the reason for the unique laws governing pharmaceutical manufacturing and its role in the pharmaceutical arena.<br><br> <b>Module 1:</b><br>   • The need for the FDA and the cGMP's in our industry<br>   • FDA enforcement<br>   • The “Act”<br>   • Introduction to 21 CFR, Parts 210 and 211<br>   • Case study from the early cGMP history<br><br> <b>Module 2:</b><br>   • CFR 21, Part 210 Definitions<br>   • The index to Part 211<br>   • A brief overview of each section of 211 with examples of <br>     how they relate to job performance<br>   • A case study of how a company uses cGMP's to gain <br>     instructions for improving their performance<br><br> <b>Module 3:</b><br>   • The 7 key areas that are necessary for compliance to the <br>     cGMPs<br>     – Follow good documentation<br>     – Keep it clean<br>     – Follow procedures<br>     – Don't make any unauthorized changes to anything<br>     – Avoid mix-ups<br>     – When in doubt, ask<br>     – The data, record and logs we create doing our job are<br>         critical; The most critical is the batch record<br><br> <b>Question and Answer Session</b>