Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022. Latest FDA inspection trends: common audit…
Medical Device Design
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
Are you ‘recall ready’ according to the FDA?
Are you ‘recall ready’? What do regulators such as the FDA, TGA, EMA or MHRA expect in terms of recall preparedness? Recall basics.
Medical device Regulations (FAQs)
Medical device regulatory compliance FAQs: When is a product considered to be a medical device? What is meant by product classification system?
Medicine Supply Shortages
Medicine supply shortages relating to the pandemic continue to wreak havoc on treatment continuity. GMP education can help reduce shortages caused by …
Medical device recalls
Reasons for medical device recalls Software issues are the most common reason for medical device recalls. Pharmaceutical companies…
PIC/S GMP: Are mock recalls required?
GMP Education Topic: Pharmaceutical Product Recalls Mock recalls help employees prepare for a recall. They also indicate to…
Bees on Cannabis & Hemp Crops
Bees on Cannabis & Hemp Crops: Good or bad…and do bees get high? Cannabis plants and insect (Honey…
Learning terminology: Upskilling vs reskilling
Training & Development Topic: Upskilling (Life Sciences Industry). Why it pays to upskill and reskill employees rather than…
10 Key Steps for Managing a GMP Compliance Training Program
Are you an experienced trainer, but new to the Pharmaceutical industry and cGMP compliance training programs? Perhaps you…
FDA Warning Letters on Data Integrity Issues
Batch release decisions — and other product safety evaluations — rely on data integrity. In this pharmaceutical industry…
FDA Warning Letters – CAPA
FDA Warning Letters for cGMP compliance issues relating to CAPAs If you’re a Pharmaceutical business owner or Quality…
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