All our GMP training courses are available on-site or as public training course in a city near you. In addition to the scheduled public courses and onsite GMP training options, we also offer online GMP training courses and eLearning options to keep your team up to date.
Half-day refresher courses for GMP, Active Pharmaceutical Ingredients (API) and contamination control are also available.
All Public Training Course are at $450 AUD + GST (2020) – Price per person per day and includes an awesome Trainer, engaging course content plus morning / afternoon tea/coffee and lunch! (not included for virtual sessions)
Unfortunately there will be no refunds for cancellations within 7 days of training delivery date.
Upcoming GMP training course dates | PharmOut’s GMP training course dates (you can book online)
PharmOut is Australia’s leading industry consultants and industry providers for instructor-led GMP classroom training courses to meet regulatory requirements.
Details of our GMP courses are listed below. You can also visit the links below for specific dates or to request a customised, onsite training.
The PIC/S Code of GMP for the manufacture of medicinal products PE 009 version 13 has been issued and came into effect in Australia on January 1st 2018 with full implementation on January 1st 2019. Not to stand still but version 14 is now issued but not yet adopted.
In this session, we will be covering the key requirements of PIC/S version 13 and the latest version 14 requirements how you and your company.
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.
Change has been a constant in our industry since the beginning but it’s never been this fast or wide; by the time we’ve understood the current tsunami of business innovations the next one is already upon us. We’re in an age where the size and experience of a company can actually be a liability – these days the key to business success is agility, not stability.
Mindset 4.0 covers all you need to know about innovation and change readiness for researchers, laboratory employees, pharmaceutical employees/engineers, validation experts, academics and more — open to anyone from a variety of industries, our industry, in particular, needs this breakthrough Mindset training course.
Designed by one of Australia’s most sought-after creative minds, this course explores the What, Why, How and What Next of business innovation and allows participants to test-drive simple but powerful thinking tools for generating, developing, testing and prioritising fresh thinking.
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.
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 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.
This Audit Training Course is designed to provide participants with detailed knowledge of internal and 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 self-inspection of internal audit program.
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. The guidances are in place to prevent falsified medicines from entering the supply chain and also to maintain control of your distribution, ensuring the quality and integrity of your products.
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.
Statistics may not be for everyone but they are a 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 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.
This Cleaning Validation (CV) Training Course is to provide participants with an overview of a typical cleaning validation program.
The course will help you understand the three phases of a lifecycle CV program (like the three stages of Process Validation) and will step through each part
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 cleanroom(s) and the processes within them.
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 covers the key concepts of ISO 14971:2019 and how to apply the standard to the medical devices industry.
Contact us for medicinal cannabis cultivation and compliance training, or for cannabis industry consultancy greenhouse architecture, extraction facility designs, cleanroom validation and related GMP engineering and audit consulting)
The cultivation and manufacture of Medicinal Cannabis is regulated in Australia by the ODC and the TGA. The regulatory processes can be a challenge for companies wanting to cultivate, process, extract and export cannabis (THC or CBD products) in Australia, even for organisations with considerable international experience. As the cannabis regulatory system is just so different, we advise you to engage us with country-specific questions. 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 cultivation problems.
Introduction to regulations and compliance in the medicinal cannabis industry.
Discussion of quality management systems (QMS), including hygiene, what makes a batch, batch traceability, basic record keeping (Good Documentation Practices or GDocP), quality risk management and Corrective and Preventive Actions (CAPA).
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.
The key mindset behind every good Pharmaceutical Quality System (PQS) is to ensure that products are consistently designed and produced in accordance with the control strategy to meet specific quality standards. This ”Quality-by-Design” thinking is complimented by validation and GMP training activities, helping you minimise risks in pharmaceutical production that are not eliminated through testing the final product.
GMP Training Courses | CAPA | PIC/S GMP | Data Integrity | Validation | More
GMP requires adequately training your employees and contractors in GMP, including vendors and subcontractors, who must be trained in industry-specific GMP for manufacturing in pharmaceutical, medicinal cannabis, medical devices. blood and tissue products, and veterinary medicines.
Is your employee, contractor and vendor GMP training up to date?
Is your regulatory knowledge/employee GMP training adequate to pass an Audit by the TGA, FDA or another regulatory body?
Do your systems and training programs help reduce your risk of deviations and recalls?
GMP Compliance Training and Audit Failures relating to inadequate employee training programs.
Ongoing, adequate training is part of your requirements and a regular TGA audit finding or GMP compliance failure.
Be sure all employees, contractors, vendors and suppliers have adequate GMP training, GDP training and regular GMP refresher courses.
If you need TGA GMP audit response assistance (or FDA/EMA and others), our team at PharmOut can assist.
We also have training courses and annual Pharmaceutical/Medical Device Industry GMP Forums (engineering, compliance, innovation) including medicinal cannabis industry sector employment requirements.
Contact us if you need a training quote or GMP compliance support including validation, engineering, cleanroom designs, self-inspection and more.
GMP Training Courses and cGMP and EU GMP Services Available including Audit Response Assistance and QMS templates
We are here to help you succeed. Our GMP training courses give you the flexibility to meet your training requirements.
PharmOut regularly offers public courses and/or onsite GMP training courses for medical device industry training, pharmaceutical industry GMP training, veterinary GMP, bio-science industry GMP/GDP training and related courses in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney.
GMP training in other countries and cities can be organised on an as-needed basis.
Our scheduled classes and custom onsite GMP training courses are delivered by our expert pharmaceutical industry trainers.
