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| Tim Anderson - AquaMarine Group (former US FDA CMC Chemist/Reviewer– CDER) |
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Why bother?
• SETTING THE TONE OF THE QUALITY ASSURANCE and even an FDA Audit BEGINS WITH YOU
• CONFIDENCE IN YOUR OPERATIONS and PROCESSES FORMS THE BASIS for a “We can handle anything that comes up” attitude
• Acquiring a cGMP mindset allows you to project TRANSPARENCY to the US FDA with confidence
• Maintaining a cGMP mindset allows you to create and maintain an envrironment where the is ZERO TOLERANCE for “SURPRISES” |
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A new era in the pharmaceutical industry has set in !
It’s no surprise that the pharmaceutical industry is not only becoming more global BUT that the center of gravity is shifting towards Asia led by China and India & other emerging regions.
India and China currently account for approximately 40-49% of the production of the g lobal API supply, but this will increase in the next 10 to 15 years to a staggering 80%! |
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For better or for worse, Western pharmaceutical companies can no longer afford to TRUST that cGMP standards practiced by your emerging regions API sourced vendors & outsourced manufacturing partners will suffice.
It’s one thing to know that they can do the job—the questions that goes begging is:
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| Will they do the job? |
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Mandating complete documentation of processes is one thing—making sure SOPS are being practiced is another. Making sure that cGMP is being practiced at the right time in the right places demands the cGMP mindset.
On December 1st – on a 60-minute webinar with FDASmart Inc , listen to Tim Anderson teach you just how to ACQUIRE AND BALANCE a cGMP mindset without overkill!
Tim Anderson is a CMC expert who served with the US Food and Drug Administration (US FDA), CDER as a Review Chemist in 1992. In this capacity Tim reviewed and granted approvals for Chemistry and Manufacturing Controls (CMC) submissions (ANDAs) at the Office of Generic Drugs.
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| Cost: $ 459 per person |
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