How To Make Your FDA Audit or FDA Inspection 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) Copyright (2015) All Rights Reserved For more information about our workshops and conferences in your area, please contact us at: