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How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to

Wednesday, September 26, 2018, 4:00 PM


How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection Management techniques can help mitigate the risk of receiving an observation for compliance gaps. Quality and GXP compliance are an opportunity, not an obligation, and are owned by everyone in the organization. For those interacting with FDA regarding submissions, as an example, every interaction with the FDA is a crucial moment for your development program, and meetings represent a culmination of compiled and scheduled work. Strategies, timelines, costs and complexity are all organized through this interaction - the stakes are high, and the outcomes are extremely important. It all comes down to strategic communication. Every facet of FDA meetings - from the information your company is providing, to scientific research and the tone and articulation of that information - must be conducted flawlessly. For example, for many medical device companies, a meeting with a US Food and Drug Administration (FDA) Advisory Committee is a high-profile, high-stress event. A successful meeting can assure regulators, patients and investors that a product is safe and effective, while an unsuccessful meeting can torpedo a product's chances of a timely approval. Why you should attend: This seminar will offer learning on the following: How a firm should prepare for an FDA inspection Ways to train employees in view of the inspection Field Management Directives Sub-Systems for Pharmaceutical and Medical Devices The emphasis on systems-based inspections...and the IOM, QSIT, CPGM and other crucial FDA reference documents How to ensure that required documentation is in place How to interact with the investigator-DO's and DON'T's What companies should do when the inspection ends Post inspection actions Why inspections are conducted and by what statutory authority The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents Define and execute proven GxP Compliance Strategies Proven Operational Readiness and State of Readiness tactics Determine optimal pathway during inspections and post-inspection correspondence and meetings Identify the visible signs of GXP compliance that are present as a daily reminder of the importance of GXP compliance with "risk-based" awareness demonstrated by companies Improve credibility and trust with FDA and other regulators Important training areas in GxP compliance and topical issues Gain a better understanding of how to interact and communicate effectively with FDA Identify the ground rules and do's and don'ts with FDA inspections Learn what FDA can request and not request during an inspection Understanding the interview process and why pre-inspection planning is critical for your company Navigate the inspection process from preparation, execution to close-out and debrief/exist interview FDA authority and process including 483s, Warning Letters, recalls, and other potential actions The FDA inspection process and approach The use of a mock audit and outside

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