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...
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.
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 Good Distribution Practice (GDP) Training is designed to cover the latest GDP requirements in the distribution and/or warehousing of Active Pharmaceutical Ingredients (API) and medicinal products. It covers the current GDP guidelines and incorporates GMP updates which contain specific GDP clauses – linking responsibilities between manufacturers and distributors of medicinal products. The Good Distribution...
This introductory one-day workshop will cover the key concepts of ISO 14971 and how to apply the standard to the medical devices industry.
Well written technical SOPs help employees understand information the first time they read or hear it. Who doesn’t want to improve compliance, shorten induction time and reduce deviations caused by confusing procedures? If you are asked to write SOPs as part of your job role, would you like some straightforward guidance on where to start...
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