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This “Two-day lecturer-led FDA virtual seminar 2021 FDA inspection points” The meeting has been added to ResearchAndMarkets.com provide.
The purpose of a regulatory inspection is to carry out an activity that should prove that your company is operating in accordance with the appropriate CFR requirements and maintaining compliance. The key to a successful audit is to be able to communicate how your quality system ensures this state of control.
In many cases, the arrival of supervisory investigators is a difficult experience for some people. In this seminar, you will learn how to correctly warn key members that investigators have arrived, how to set up the correct protocol for the inspection room and any related “war” rooms that support the inspection, and how to manage the investigators’ requirements during the investigation. Timely and accurate way. This preparation can minimize the stress and confusion during the inspection process.
Working in a highly regulated industry, we know that our company must always be “ready.” This is not only to maintain good rapport with regulatory agencies, but also to our customers and patients who use our products as a commitment to quality.
Regulatory inspections should be the time to prove your company’s high degree of compliance with regulations and customer safety and quality. The purpose of regulatory inspections is to ensure that your facility complies with FDA rules and regulations. Researchers want to know that the product is correctly manufactured and that current good manufacturing practices comply with FDA standards. Inspections may pose a great threat to all relevant personnel, but it is essential if you wish to conduct inspections to produce satisfactory reports.
The inspection management plan should provide the following: response to the arrival of investigators, guidelines for inspectors’ activities, procedures for cooperating with investigators, and inspection documents. The management plan or SOP should state all the procedures you will follow during the investigation. Personnel training is a key variable that should be inspected before any inspection. Introduce the inspection process to the personnel so they are ready. Train individuals to communicate with FDA investigators. Confirm that personnel have been provided with training on their current job functions, and support records have been recorded. The goal is to minimize the chance of incorrect answers or excessive information provided to the inspector. Also make a list of what should and should not be done when talking to the inspector.
Why are you attending
If you are well prepared, there is no need to worry about FDA inspections. FDA inspections revealed some trends in recent years. The agency has taken a tougher stance on the quality system and adopted a risk-based approach. Inspectors will usually review at least two (2) systems in depth. Quality inspection has been the top priority in recent years. They may also consider other systems such as facilities and equipment, materials, production, packaging and labeling or laboratory control.
The FDA does not expect your facility to be perfect. They hope that all companies will encounter some problems. What they really want to see is how you solve the problem. The FDA tends to believe that companies that control these problems have higher quality standards. This seminar will help you use FDA inspections as a learning tool, rather than a negative or adversarial experience.
learning target
After the meeting, participants will:
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Study pre-planning and preparation activities
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Know what to do when the investigator arrives
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Know the documents to prepare and prepare
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Develop inspection tasks and responsibilities
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Pay attention to the precautions of inspection
Agenda:
DAY 01 (10:00 am-3:00 pm Eastern Time)
FDA inspection 101
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FDA unannounced visit-how to prepare and respond
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Preparing for FDA review/PAI preparation-what should the training of key participants look like
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Basic concepts that everyone regulated by the FDA should adopt-review quarterly quality topics to stay up to date
Company preparation
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How does the company prepare for such a situation-training for SMEs and other fields
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How can the company balance the need to prepare for potential FDA investigations or enforcement actions while still maintaining a profitable business
Day 2 (10:00 am-3:00 pm Eastern Time)
Observed lessons
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How should companies respond to 483 observations or warning letters-deadlines, follow-up and closure
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Lessons learned-review of observation results and overall inspection experience
Real life situation
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Case scenario-review the real scenarios you may encounter during the inspection
For more information about this meeting, please visit https://www.researchandmarkets.com/r/k83svh
About ResearchAndMarkets.com
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