Public GMP and Quality Training Courses

We are here to help you succeed.

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. Alternatively our Onsite training  or eLearning are other ways to keep your GMP knowledge up to date.

Please note all our training requires you to Bring Your Own Device (BYOD)

To participate in  our unique, innovative, cost-effective and paperless training, you must bring your own device. We will supply an internet connection and free WiFi in all venues.

Price per person includes morning tea, lunch and afternoon tea

Australian Medicinal Cannabis Training Course

**New**

In Australia the cultivation and manufacture of Medicinal Cannabis is regulated by the ODC and the TGA which is a challenge for companies even with considerable international experience, as the Australian system is just so different. In addition as you design, build, validate and operate your Medicinal Cannabis facility, you will bump into a host of additional red tape and practical problems.

To solve this challenge, the “Australian Medicinal Cannabis” Training Course is hot off the press.  This 1-day course will give you everything you need to know to get started on your journey.

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GMP Facility Design**New** GMP Facility Design Training Course

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 of a GMP facility. The course covers both sterile and non-sterile facilities and also addresses the essential requirements of critical utilities that serve the cleanrooms and the processes within them.

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*Most Popular* PIC/S GMP Training Course PE009 Version 13

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 on January 1st 2018.

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.

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Annex 1*HOT* Draft PIC/S Annex 1  training

The European Medicines Agency (EMA) and PIC/S have published the public draft of the long-awaited revision to Annex 1 of their GMPs, for the Manufacture Sterile Medicinal Products.

This training course will dive deeper into the revisions and highlight changes that need to be considered for sterile manufacturers with markets subject to EMA or PIC/S.

You may be required to comply quickly with these new changes, so come along to this training session and hear from the experts who have been following the changes closely over the last couple of years.

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data-integrity

Data Integrity Training Course

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.

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GMP SOP Technical Writingtechnical writing

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?

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Quality Risk Management Training (ICH Q9)manufacture-sterile-medicinal-products

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.

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ISO 13485: 2016 – Quality Management SystemsQMS templates

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).

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ISO 14971 Quality Risk Management Training  – Devicessampling

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.

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GAMP & Computerised Systems Validation Training Coursecomputerized-systems

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 Integrity Guidance.

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Process Validation Training Coursecomputer systems validation templates

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.

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Good Laboratory Practice Training Coursegmp bundles

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.

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Statistics for Process Validation Trainingprocess validation

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.

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Self Inspection (Internal Audit) Traininggood-record-keeping

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.

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Cleaning Validation Trainingmanufacture-sterile-medicinal-products

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

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Good Distribution/Warehouse Practicegood-distribution-practice

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.

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CAPA Traininggmp bundles

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.

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PIC/S GMP Hong Kong

PIC/S GMP Update Hong Kong

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.

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Register for a GMP course today and get your training started!

If you need any assistance, would like a quote for personalised training, have any ideas for training we could design for you, or just have a general training question, please don’t hesitate to contact us.