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PharmOut regularly offers GMP training courses and events in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney. Other countries / cities can be organised on an as needed basis, contact us to discuss. Our Onsite training or eLearning are alternative ways to keep your GMP knowledge up to date.
The new PIC/S Code of GMP for the manufacture of medicinal products PE 009 version 13 have been issued and is due to come into effect in 2017.
In this session, we will be covering the most significant changes since the publication of the old version 8, the new version and how it impacts Australian and New Zealand manufacturers.
Data integrity is not new- it is implicit, and always has been, as a foundation of good manufacturing practice. The subject however has an increased profile as hybrid (paper and electronic) and electronic systems become more prevalent in modern manufacturing. Globally regulators are recruiting and training their inspectors in data integrity and they are identifying increasing numbers of GMP violations linked to data integrity.
This Good Manufacturing Practices, GMP Training Course is designed to introduce someone new to a cGMP regulated environment or someone just needing a refresher in the latest GMP changes. It covers the current EU, PIC/S, FDA and TGA GMP guidelines and recent updates.
Well written 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 and how to write?
This Quality Risk Management training is focused on how the regulations apply to everyday pharmaceutical manufacturing processes and to accurately assess the risk to the patient.
This full day course covers the key concepts of the Quality Management System (QMS) standard ISO 13485 and how to apply these to the sponsorship and manufacture of medical devices (including In-Vitro Devices).
This introductory one day ISO 14971 training course is covers the key concepts of ISO 14971:2007 and how to apply the standard to the medical devices industry.
This training course on how to validate computer systems covers the essential principles on how to use a risk based approach in Computer Systems Validation (CSV), and will include an overview of the latest FDA Data Intergrity Guidance.
This one-day Process Validation training course is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the FDA in 2011 and the EU, PIC/S Annex 15 in October 2015 and to provide practical insights into how “modern validation” is carried out and avoid common and costly mistakes.
This Good Laboratory Practice Training (GLP) training course is updated regularly to provide participants with current GLP trends and information. This course is designed for staff working in the early phase drug development and commercial operations.
Statistic may not be for everyone but they are fundamental part of GMP and all stages of process validation.
We have developed an interactive course that will keep you engaged throughout the day as you develop a practical understanding through workshops and discussion of statistics in process validation including: understanding variability, statistical inference, Design of Experiments (DoE), control charts and more.
This Internal Audit Training Course is designed to provide participants with detailed knowledge of self inspection or internal 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 self inspection of internal audit program.
This Cleaning Validation (CV) Training Course is to provide participants with an overview of a typical cleaning validation program.
The course will help you inderstand the three phases of a lifecycle CV program (like the three stages of Process Validation) and will step through each part
This Good Distribution Practice (GDP) Training Course is designed to cover the latest GMP requirements in the distribution and/or warehousing of medicinal products. It covers the current GMP guidelines and recent updates.
The course will help you understand the importance of correctly managing an integrated supply chain. Distribution networks are becoming more and more complex and involve multiple parties. We will help you to identify the appropriate tools to assist you to. The guidances are in place to prevent falsified medicines entering the supply chain and also to maintain control of your distribution, ensuring the quality and integrity of your products.
The purpose of this Sterile/Aseptic Manufacturing Training Course is to provide you with a basic understanding of the concepts, principles and practices used in the manufacturing sterile medicinal products.
The course will help you to understand the important aspects of the aseptic/sterile manufacture of medicinal products and the regulatory expectations.
This CAPA Training Course 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.
The purpose of this course is to provide participants with a detailed understanding about the practical application of the GMP codes and guidelines to the design, installation, commissioning, and start-up of cleanrooms. The course also addresses the essential requirements of critical utilities that serve the cleanrooms and the processes within them.
The purpose of this training course is to provide an understanding of the European GMPs and in particular, Eudralex Volume 4 GMP regulations (including changes to Chapters 3, 5, 6 and 8).
This course will help you compare the European EU GMP to other GMP codes and in particular, the subtle differences when compared to PIC/S PE 009 GMP.
This PIC/S GMP Update Hong Kong Training Course is designed to introduce someone new to the current PIC/S GMP regulated environment or someone just needing a refresher in the latest PIC/S GMP and global changes. It covers the current PIC/S GMP guidelines and includes recent updates on the hot topics of Data Integrity and proposed updates to Annex 1 on sterile manufacture.
Visual Inspection of Parenterals and the Life-Cycle of Particulate Matter/Physical Defect
Particulate matter in the final filled product is additive, potentially coming from many materials and manufacturing steps throughout the process. Each of these potential sources must be monitored and controlled. Elimination or minimising particles or physical defects is best addressed as early in the process as possible. Each portion of the life-cycle must be analyzed for scientific and logical particulate controls that when added collectively in the finished product will not exceed the regulatory limits for foreign particulate content. Some parenterals such as lyophilized powders, suspensions, emulsions and protein based solutions are difficult or impossible to visually inspect for particulates and require even more consideration for upstream controls to yield acceptable finished product.
This full-day course includes a brief overview of the ISO 14644 series to help attendees become familiar with the breadth of work being undertaken by the ISO/TC 209 Technical Committee. However, the majority of the course will cover nuts and bolts of and recent updates to ISO 14644-1 (2015): Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration, and ISO 14644-2 (2015): Cleanrooms and associated controlled environments—Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, in their entirety.
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If you need any assistance, would like a quote for personalised training, or just have a general training question don’t hesitate to contact us.