<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends and provided in-depth case studies from recent drug Good Manufacturing Practice (GMP) inspections illustrating agency concerns […]

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends and provided in-depth case studies from recent drug GMP inspections illustrating agency concerns and findings. Barreto-Pettit […]

Next week, a virtual conference will feature a presentation by Redica Systems Senior GMP Quality Expert Jerry Chapman, one of our Industry Experts. Jerry took a few minutes to answer some questions about his talk. Conference Details Date: Wednesday, April 14Event: Society of Quality Assurance Annual MeetingPresentation by: Redica Systems Senior GMP Quality Expert Jerry […]

Gene therapies are an emerging and promising field of medicine that offers cures for rare and debilitating diseases, often at exorbitant cost. The science supporting them is complex and serious side effects are possible. Consequently, manufacturers of gene therapies must be forthcoming and transparent with information provided to regulatory agencies and patients. When that transparency […]

During FY2020, FDA’s Center for Veterinary Medicine (CVM)—though hampered by travel and facility visitation limitations due to the COVID-19 pandemic—completed 263 domestic and 13 foreign animal food inspections and 48 domestic and 14 foreign animal drug inspections. Resulting from those inspections were 11 animal food warning letters and four untitled letters, seven animal drug warning […]

The U.S./EU mutual recognition agreement (MRA) is bearing fruit in the form of inspections being performed by partner agencies accepted by the other MRA agencies in lieu of performing inspections themselves.  For example, the U.S. FDA has received over 200 inspection reports from European health authorities and deferred nearly as many European inspections. At the […]

As health authorities around the world wrestle with how to conduct manufacturing inspections during the 2020 global pandemic, as well as with shrinking resources and the need to better leverage them, mutual recognition agreements (MRAs) between the authorities are providing some relief. [Related: Learn how our Redica Systems platform can help you prepare for your […]

Next week, a virtual conference will feature a prerecorded presentation by Redica Systems Senior GMP Quality Expert Jerry Chapman, one of our Industry Experts. Jerry took a few minutes to answer some questions about his talk. Conference Details Date: Wednesday, March 17Event: virtual 2021 PDA Annual MeetingPresentation by: Redica Systems Senior GMP Quality Expert Jerry […]

As onsite pharma FDA inspections resume in earnest, the agency will use state advisory level rating systems for the areas where manufacturing sites are located to help determine whether to inspect onsite at any given location. The agency is also considering how to best perform remote drug inspections for circumstances in which onsite agency presence […]

As the COVID-19 pandemic continues and in-person activities and travel remain restricted, FDA has been making pharma inspection decisions using rules and policies that are not understood by the industry. The decisions can be a source of consternation for those hoping to be inspected—for example, as part of a new drug approval or for clearing […]