Search Results for: annex 15

Regulations-Blood-and-tissue-products-TGA
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Blood, Tissues, Biologicals & ATMPs Regulations in Australia

Ensuring Safety and Integrity: The Significance of Blood, Tissues, Biologicals & ATMPs Regulations in Australia In Australia, medicinal products sourced from human blood or tissues represent a critical component of the healthcare system. Blood, blood components, tissue-derived products, biologicals and ATMPs are regulated by the Australian TGA (Therapeutic Goods Administration) under the Therapeutic Goods Act…

Artificial intelligence in the medical device industry AI use trends
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Artificial Intelligence in the Medical Device Industry

Top 10 AI Trends in the Life Sciences Industry Artificial Intelligence in the Medical Device Industry (Part 2). This article describes AI trends #6 through #10 of the Top 10 Artificial Intelligence use trends in the life sciences. It provides an overview of AI use trends in the Medical Device Industry & for quality control)….

Artificial intelligence (AI) in the pharmaceutical industry (AI trends in healthcare).
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Artificial intelligence in the Pharmaceutical Industry

How is artificial intelligence in the pharmaceutical industry impacting manufacturing trends? (Part 1) Top 10 uses of Artificial intelligence in the Pharmaceutical Industry Artificial intelligence technology is rapidly expanding, enabling the delivery of precision medicines and safer interventions. The use of artificial intelligence in the pharmaceutical industry & healthcare sectors has the capacity to: What…

reasons for medical device recalls reasons FDA TGA 2022
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Medical device recalls

Recalls related to software issues Software issues are the most common reason for medical device recalls. Medical device manufacturers (similar to pharmaceutical manufacturers) should be prepared to implement recall actions, when necessary. While quality testing occurs throughout manufacturing, including final checks prior to market release, sometimes a quality issue may be discovered after the product…

gmp-compliance-training-program
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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 are a business owner – or recently promoted into a Quality Management role – with responsibilities for training new hires and long-term employees? If you’re looking for recommendations for best-practice cGMP training, this article is for you….

who-conducts-gmp-audits-PICS-TGA-
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GMP Audits: Regulatory Authorities List

Who regulates GMP (Good Manufacturing Practice)? Who conducts GMP audits? Answer: Regulatory Authorities vary from country to country. Examples of Regulatory Authorities overseeing the pharmaceutical and/or medical device manufacturing sectors include the US Food & Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the European Medicines Agency (EMA) in the EU, and the MHRA…

10-ways-to-cut-training-costs-gmp
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10 Ways to Cut Your Training Costs for GMP

How do you match the average training budget with your employee training needs?  And how can you best keep your employees’ GMP certificates (evidence of their training course completion) up to date? It’s a known challenge in training sectors that annual training BUDGETS can be difficult to match with employee training NEEDS at times. Yet…

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