This presentation provides you with no nonsense methods to prepare for an FDA audit confidently and also improve processes. To know more about our workshops visit www.fdamap.com
You can also visit http://www.fdamap.com/registration_workshop.html to register for the workshop you would like to attend.
2. MANAGERS IN PHARMA COMPANIES ARE USUALLY QUITE
WORRIED ABOUT FDA INSPECTIONS AND AUDITS
3. IT’S OBVIOUS AS MILLIONS OF DOLLARS ARE INVESTED IN
PRODUCT DEVELOPMENT AND IT’S ALL AT STAKE WHEN A
PRODUCT IS AWAITING FDA APPROVAL
4. IN THIS PRESENTATION WE WILL GIVE YOU SOME TIPS AND
SUGGESTIONS TO ENABLE YOU TO IMPROVE THE PROCESSES IN
YOUR COMPANY SO THAT YOU CAN EASILY PASS THE FDA
INSPECTION/AUDIT.
5. THESE TIPS WILL NOT
QONLY HELP YOU IN THE FDA
AUDIT BUT ALSO IN THE OTHER
AREAS OF OPERATIONS AND
PROCESSES.
6. FIRST OF ALL LET’S KNOW WHAT IS FDA AND WHAT
ARE ITS RESPONSIBILITIES.
The chief role of the FDA is to make sure the health of the US citizens is
protected. They also keep tabs on the products available in the market
specially with regard to their effectiveness and any probable side-effects.
FDA is the US government
watchdog that controls the
food and drugs being sold in
the states.
8. ABOVE ALL FDA MAKES SURE THAT
NO COUNTERFEIT OR DIVERTED
DRUG IS DEVELOPED AND SOLD IN
THE STATES.
9. DON’T BE SCARED OF AN FDA INSPECTION AS WE ARE
GOING TO SHARE WITH YOU SOME TRIED AND TRUSTED
METHODS YOU CAN USE TO NOT ONLY PASS THE
AUDIT BUT ALSO ENHANCE THE QUALITY OF YOUR
INTERNAL PROCESSES.
11. ASK YOUR INTERNAL AUDITORS TO
SUPERVISE AND MONITOR THE
PROCESSES.
ASK THEM TO GO BEYOND MAKING
RECOMMENDATIONS.
AUTHORIZE THEM TO
CHANGE/TWEAK PROCESSES
13. Hire third party auditors from outside and arrange fierce mock
audits to expose your teams to real life FDA audit scenarios
14. IT HAS DUAL BENEFITS:
First, the analytics of the overall
processes will be easier for you and
you will be able to measure the
performance of your company and
the procedures ;
Secondly, the training of your team
would be an added bonus for real-
life FDA audit.
15. If you claim something, be ready with its evidence
16. If the investigator asks for any specific
document, be ready with that document
18. www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg,
MD 20879
Email: info@FDAMap.com | Phone: 410-501-5777 | (C)
Copyright (2015) All Rights Reserved
For more information about our
workshops and conferences in your
area, please contact us at:
