This Auditor Training Course is designed to provide participants with detailed knowledge of self-inspection or external auditing best practices. This course will help you to understand how and why you need to monitor your GMP systems and how to identify, record and address necessary corrective actions and continuous improvement items as part of your internal...
This Quality Risk Management (QRM) course is focused on how the QRM regulations apply to everyday pharmaceutical and biotech manufacturing processes and to accurately assess the risk to product quality and patient safety. As discussed at the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: “…the importance of quality...
This course applies to manufacturers of veterinary medicinal products. Veterinary medicinal products are required to be fit for their intended use and not place treated animals or users at risk due to inadequate safety, quality or efficacy. The manufacture of veterinary medicinal products must ensure their products meet their registration requirements and there is batch-to-batch...
We are offering a 1-day training course covering the essential “what you need to know” when it comes to GMP Part I Manufacturing Medicinal Products. Learn about the key requirements in each of the 9 chapters including the main inspection focus areas and how to avoid an audit finding.
This one-day ISO 13485 workshop covers the requirements of ISO 13485 and its implications within a medical device manufacturing company. PharmOut’s consultants regularly design and write Quality Management Systems for companies, from the smallest to the large blue-chip companies. They have many practical suggestions on how to apply the ISO 13485 standard and with ready...
This Auditor Training Course is designed to provide participants with detailed knowledge of self-inspection or external auditing best practices. This course will help you to understand how and why you need to monitor your GMP systems and how to identify, record and address necessary corrective actions and continuous improvement items as part of your internal...
This Audit Preparation Training Course is designed to provide participants with detailed knowledge of the external audit process and the roles and responsibilities of an auditee. This course will help you to understand how to prepare your work environment, what to expect on the day of the audit (both onsite and remote audits), what auditors...
We are offering a 1-day training course covering the essential “what you need to know” when it comes to GMP Part I Manufacturing Medicinal Products. Learn about the key requirements in each of the 9 chapters including the main inspection focus areas and how to avoid an audit finding.
This CAPA Workshop is designed to provide you with an overview of a typical Corrective Action and Preventive Action (CAPA) program to handle outputs as part of a Pharmaceutical Quality System (PQS). This course will help you to understand how to run an effective CAPA process and use it for continuous improvement.
This course applies to manufacturers of veterinary medicinal products. Veterinary medicinal products are required to be fit for their intended use and not place treated animals or users at risk due to inadequate safety, quality or efficacy. The manufacture of veterinary medicinal products must ensure their products meet their registration requirements and there is batch-to-batch...
This one-day Validation training workshop is designed to provide an overview of the current concepts and guidance documents for Validation as defined by the US FDA in 2011 and PIC/S Annex 15 Qualification and Validation. The aim of the course is to provide practical insights into how validation is carried out and avoid common and...
PharmOut has been training on Computer Systems Validation since 2008, much has changed recently, surprisingly Data Integrity remains a hot topic with regulators. This course examines the latest GAMP 5 second edition, including the new chapters on cloud storage, Artificial Intelligence, Machine Learning, and Blockchain) as well as recent developments, i.e. FDA’s draft Computer Software...
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Phone: +61 3 9887 6412
Email: info@pharmout.net
