Communication Documentation Events Labelling 
pharmaphorum
MAY 25, 2022
When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. Identifying the appropriate code and label.
GMPSOP
AUGUST 23, 2022
Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. Assessing validation failures/deviations 4. All written and updated by GMP experts.
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Viseven
NOVEMBER 17, 2022
Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.
FDA Law Blog: Biosimilars
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
GMPSOP
AUGUST 28, 2023
Raw materials must be inspected to confirm that the containers are intact, have been provided according to the paperwork, and have labels affixed on them identifying the raw material name, batch number, and expiry date. For example, materials with Hold, Quarantine, or Rejected labels must be kept in a quarantine location.
GMPSOP
MARCH 4, 2023
Quality risk management involves the art and science of identifying, analyzing, assessing, and managing uncertain events. Events that can impact product quality or compliance with registered dossier throughout a product’s life. Additional documents included each month. All written and updated by GMP experts.
Quality Matters
AUGUST 3, 2023
ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g., This risk assessment effort is not a one-time event but rather a periodic, recurring process for communicating and reviewing risks,” noted USP’s Horacio Pappa, Ph.D., active ingredients, excipients, other raw materials) Packaging materials (e.g.,
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