GMP Code: Blood and Tissue Products (TGA Regulations)
Allow 2 to 3 hours.
Search Results for: TGa
Top 10 GMP Audit Citations: FDA & TGA Inspections
FDA & TGA GMP Compliance Audit Citations for 2020, 2021, & 2022. Latest FDA inspection trends: common audit findings (2020-2022) During the pandemic, manufacturers experienced unprecedented supply chain disruptions and product transport issues. Read more on APIs, medicines and medical device shortages related to the impact of the pandemic. Impact of the pandemic on TGA and…
Release for Supply – TGA
Course duration: Allow 1.5 to 2 hours to complete this course.
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…
Regulatory Authorities: Veterinary Medicines
Regulatory Authorities Veterinary Medicines (Regulatory compliance series) In our article on global regulatory authorities for human-use medicinal products, we covered a range of regulatory authorities in different countries. In this article, we’ll explore Regulatory Authorities for Veterinary Medicines in different countries. We’ll also list key regulations that apply to veterinary medicine production in those countries….
GMP Education Programs
GMP Education Programs: Why is repeated GMP training (as part of your PQS) so important for sustaining a “GMP compliance culture?:
Counterfeit Drugs: A Growing Problem
Counterfeit drugs (fake pharmaceuticals and adulterated medicines) are a growing problem around the globe. It is estimated that counterfeit medicines: Counterfeit drugs also damage consumer trust in pharmaceutical products and healthcare providers. This results in poor adherence to recommended treatments, with subsequent deterioration in health conditions. There is a mistaken belief that counterfeit medicines are…
Prevention of Falsified Medicinal Products
Allow 1 to 1.5 hours.
Top 10 Interview Questions in the Pharmaceutical Industry
Top 10 Interview Questions in the Pharmaceutical Industry.
ISO 22442-2 Medical Devices Utilising Animal Tissues or Derivatives
Course duration: Allow 2 to 3 hours to complete this course.
Understanding cGMP Certification
For therapeutic goods to reach patients and consumers, they must be shown to meet Good Manufacturing Practices (GMP). GMP Certification is one such means of demonstrating this compliance. cGMP Certification, representing ‘current Good Manufacturing Practice Certification), is another term referred to by Regulatory Authorities in various jurisdictions, e.g. the US FDA. In this blog we…
MDSAP Training – Medical Device Single Audit Program
Course duration: Allow 2 to 3 hours to complete this course.
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