DUBLIN--(BUSINESS WIRE)--The "Managing Your FDA Inspection: Before, During and After" conference has been added to ResearchAndMarkets.com's offering.
This course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it.
"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers.
We all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problems, the bad public relations, upset customers and future business plans can be set into a downward spiral. If you do not understand what FDA is doing or thinking, how can you expect to deal successfully with FDA? If you don't know how to anticipate an investigator's actions or follow their train of thought, you will not be able to mitigate the effect of inspectional findings.
"Is FDA going to send us a Warning Letter?" You can make a reasonable prediction if you understand your inspectional results and how FDA will "grade" it. The tools are available.
Day 1 Schedule
- Lecture 1: FDA Inspection authority
- Lecture 2: Types of Inspections: purpose, scope and scrutiny
- Lecture 3: Impact on you during and after inspection
- Lecture 4: FDA Investigator Training - This is what they are thinking
- Lecture 5: Investigations Operations Manual
Lecture 6: Investigations Operations Manual (continued)
Day 2 Schedule
- Lecture 1: FDA Form 483 - List of objectionable conditions, aka list of observations
- Lecture 2: Your written response to a 483
- Lecture 3: FDA Warning Letter - advisory of possible legal action
- Lecture 4: FDA Enforcement Actions
For more information about this conference visit https://www.researchandmarkets.com/research/tv6gjv/2_day_course?w=4