The U.S. Food and Drug Administration agency, the FDA is the main watchdog that is responsible for drug evaluation and research. So, they evaluate new drugs before they can be launched in the market. Its objectives include preventing quackery, ensuring safety of human lives and providing doctors and patients the required information needed to use drugs wisely. Therefore, FDA Audit/Inspection sounds scary for many drug manufacturers and pharma companies. This slideshare will guide you to make your inspection or audit a success.

1. FDAMAP
Making Regulations Easy….
How To Make Your FDA
Audit/Inspection A Success?
www.FDAMap.com
Email: Info@FDAMap.com
410-501-5777
20203 Goshen Rd, Suite 261
Gaithersburg, MD 20879

2. ARE YOU A MANUFACTURER
GETTING READY FOR AN FDA
AUDIT AND INSPECTION?
If Yes, then…
• As a first step, you must have a fair
understanding of how FDA functions.
• You should know the processes and
systems involved with an FDA inspection.

3. SIMPLIFYING THINGS FOR
YOU…
There is a lot of study material available
online about FDA audits and inspections on
FDA’s official website, but plethora of
information may dazzle or confuse you.
In this presentation, we will discuss the study
material and training you need to make an
FDA audit a success.

4. WHAT IS THE BEST SOURCE OF
AUTHENTIC INFORMATION ABOUT
FDA PROCESSES?
You can always refer to the official website
of FDA, which is www.fda.gov for any
information you need about FDA processes.
For example, for internal FDA processes, you
can refer to FDA Manuals such as Regulatory
Procedures Manual (RPM). For additional
information on this subject, you can refer to
Compliance Policy Guide (CPG).

5. For this, always refer to Investigations
Operations Manual (IOM). It can be found
on FDA’s website.
DO YOU WANT TO KNOW THE
PROCESS & REQUIREMENTS FOR
FDA?

6. HOW TO KNOW THE CURRENT
POSITION OF FDA FOR ANY
SPECIFIC TOPIC?
To know the current position of FDA on any
topic, refer to Guidance Documents. For
further information, you can attend FDA
workshops and FDA seminars meant for
training and guidance.

7. DO YOU NEED TRAINING
FOR FDA
INSPECTION/AUDIT?
Yes, in order to effectively prepare for
these inspections, the companies
should arrange training for their in-
house staff.
Sometimes even the smaller issues
such as nervousness, contradiction of
statements by the team members,
and arguing with FDA representatives
can raise the curiosity level and
suspicion. If you are looking for
regulatory affairs and compliance
training, contact FDAMap today!

8. FDAMAP WILL TRAIN YOU ON HOW TO
PREPARE FOR MEETINGS WITH THE FDA,
THE BEST PRACTICES AND DO’S AND
DON’TS, ETC.

9. FIND A TRAINER, WHO IS WELL VERSED
WITH REGULATORY AFFAIRS AND HAS
A LOT OF EXPERIENCE DEALING WITH
FDA AND GETTING PRODUCT
APPROVALS.
FDAMap has expert trainers and speakers
working for it. These are highly experienced
individuals, who are already well-known in
the pharma industry and have years of
international experience in providing
regulatory consulting services and training.

10. www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg,
MD 20879
Email: info@FDAMap.com | Phone: 410-501-5777 | (C)
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