Behaviors Leading to FDA inspection Disruption. Avoid It
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Speaker : MOHAMMAD ELNADI
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When : Wednesday, January 15, 2025
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Time : 01 : 00 PM EST
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Mohammad has a unique blend of both technical and regulatory experience and qualifications he gained from his +18 years’ experience in the pharmaceutical industry. After graduating in pharmaceutical science from the University of Cairo, He has held posts in the fields of R&D and production of pharmaceutical dosage forms and as a contract manufacturing coordinator then, after completing postgraduate certificate in management from the American university in Cairo (AUC). He has senior management roles in business development in pharmaceutical industry including opening new markets in local & export markets which allowed him to deal with different regulatory health authorities & business environments.
He successfully led his team in cooperation with colleagues from other departments within the companies in many market access projects in many international markets.
Also, He was responsible for establishment of supply chain department in many pharmaceuticals Co. leading planning, local &foreign purchasing and warehouse functions in the company.
Now, Mohammad is a regulatory consultant for many pharmaceutical companies & international speakers providing his courses &webinars worldwide in regulatory affairs, quality &supply chain topics related to the pharmaceutical industry.
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) was signed into law. Section 707 of FDASIA added section 501(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” Section 707(b) of FDASIA required the Food and Drug Administration (FDA) to issue guidance that defined the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).
This guidance covers facilities that are subject to drug or device inspection under section 704 of the FD&C Act.1 This guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of section 501(j) of the FD&C Act.
Areas Covered
- Introduction to the new guidance issued by the US FDA regarding the circumstances that constitute delaying, denying, limiting or refusing a Drug or Device inspection
- Types of companies targeted by this guideline
- Behaviors considered a delay of inspection
- Behaviors considered a denial of inspection
- Behaviors considered a limitation of inspection
- Consequences of refusal to permit entry or inspection by FDA inspectors
Who Should Attend
- QA managers
- Compliance managers
- Regulatory affairs managers
- Factory managers
- Top management
Why Should You Attend
- To be aware of some behaviors that occur during the inspection and could result in considering your products “adulterated”
- Learn more about the way of thinking of FDA inspectors, so you can be well prepared for their inspection.
- To be well prepared for difficult scenarios and suddenly raised issues
Topic Background
Inspection by the FDA is an essential and critical part of the market access process to the USA market, so passing this phase is mandatory either during the first inspection or during periodical/random inspections.
So, to avoid losing this market, drug, and device manufacturers must be aware of the way of thinking of FDA inspectors to be well prepared for their inspections and to avoid some behaviors that annoying them and lead to denying, limiting, or delaying inspections and hence the products are considered adulterated.
US FDA recently issued new guidance describing these behaviors to avoid them during their visits to the drugs and devices manufacturing facilities and that is what will tackle in this webinar.
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$199.00
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