GMP Training Courses

PharmOut is Australia’s leading industry consultancy firm and Australia’s leading industry providers for instructor-led GMP classroom and virtual training courses. All our GMP training courses are available on-site, virtually or as a 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.

  • View or Register dates of upcoming GMP training courses (scheduled public courses)
  • Contact us for a custom ONSITE training course for your pharmaceutical manufacturing site or a nearby location
  • Or visit our GMP e-learning course listings. Online GMP training courses are also available for basic GMP orientation for specific industries including sterile manufacturing, veterinary medicines, and more.

All Public Training Virtual Courses are $500 AUD + GST and Public Classroom Courses are $550 AUD + GST – 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 or credits for cancellations within 7 days of the training delivery date.

Get In Touch

If you would like to learn more about our trainings, check availability or prices, request a quote for onsite trainings or ask any questions please fill out our enquiry form here. Alternatively, register online from the list of public course dates.

PIC/S GMP Training**Most Popular* PIC/S GMP Training 

This GMP training course covers all you need to know about PIC/S Part 1 – Manufacture of Medicinal Products. The GMP training covers all of the 9 Chapters and focuses on the “hot topics” and recent inspection deficiencies so you can avoid the same non-conformance’s.

This PICS GMP training course is designed as a practical workshop with lots of discussions and activities and will leave you with an action list to take back to your organisation and implement some Continuous Improvement initiatives.

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APVMA-GMP-TrainingAPVMA GMP Training

The purpose of this workshop is to provide participants with an understanding of the APVMA code of GMP, including any latest guidance and GMP focus areas. It is a collaborative workshop, designed to have all staff working together to improve the quality of their systems, products and service.

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Cosmetics-GMP-TrainingCosmetics GMP Training – ISO 22716

The purpose of this workshop is to provide participants with a practical understanding of the cosmetics GMP guidelines, including any latest GMP focus areas. It is a collaborative workshop, designed to have all staff working together to improve the quality of their systems, products and service.

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Australian-code-of-GMP-for-human-blood-and-blood-components-human-tissues-and-human-cellular-therapy-productsAustralian code of GMP for human blood and blood components, human tissues and human cellular therapy products

This course applies to manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.

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CAPA Training

This CAPA Training Course is designed to provide you with an overview of a typical Corrective Action and Preventive Action (CAPA) program, including in-depth use of root cause analysis tools and techniques.

This course will help you to understand how to run an effective CAPA process and use it for continuous improvement.

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Mindset 4.0 Masterclass masterclass-mindset-4-0-pharma-4-0

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.

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sop-technical-writingSOP Technical 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, R1)manufacture-sterile-medicinal-products

This Quality Risk Management training is focused on how the regulations apply to everyday pharmaceutical manufacturing processes. Per ICH Q9 (R1)and Annex 20 quality risk management guidance, you’ll explore the importance of identifying potential hazards and accurately assessing risks to patients.

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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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Good Laboratory Practice Training Course (non-clinical)gmp 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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Auditor Traininggood-record-keeping

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 the internal audit program.

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audit-preparation-workshopAudit Preparation Workshop

This Audit Preparation workshop 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, what auditors will ask for or look for, and how to respond to audit findings. It will help take the stress and anxiety out of an upcoming audit and leave you feeling ready for the audit day.

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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 PIC/S GDP guidelines and the Australian code of Good Wholesaling Practice requirements.

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 guidance’s 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.

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GMP | Validation Training Courses

Validation Workshopprocess validation training courses - pharmaceutical validation courses across lifetime - computer systems validation templates

This one-day validation workshop is designed to provide participants with a comprehensive understanding of the principles and practices involved in commissioning, qualification, and validation (CQV) in the pharmaceutical, biopharmaceutical and medical device industries. Through a combination of facilitated presentation, case studies, and interactive discussions, participants will gain the knowledge and skills necessary to effectively plan, execute, and manage CQV activities in their organisations.

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Statistics for Process Validation Trainingprocess validation

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.

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Computer Systems Validation Training Course,
Medicinal Products and Medical Devices

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 Artificial Intelligence, Machine Learning, and Blockchain) as well as recent developments, i.e. FDA’s draft Computer Software Assurance (CSA) Guideline, and of course the PIC/S Data Integrity guidance PI041. Aside from shifts in regulations, there have been significant technological shifts too, as part of Pharma 4.0TM, we have Software as a Medical Device (SaMD) and Software in a Medical Device. The computer systems validation course will cover both medical device and medicine regulations and recent challenges posed by emerging technologies like IoTs.

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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 understand 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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GMP Facility Design Training CourseAnnex 1

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.

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Medical Devices | ISO13485 Training Courses

QMS templates - quality management training courses for pharmaceutical and medical device industry

ISO 13485: 2016 – Quality Management Systems

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  – Devicespharmaceutical sampling training courses - medical devices and pharmaceutical gmp courses

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.

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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 using our enquiry form.

Or click here for the Calendar of upcoming GMP courses (open to the public).

Why our GMP and EU GMP training courses are top-rated for the pharmaceutical industry!

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.

Need GMP training fast for new starters? Try our online GMP training courses.

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.
  • Or visit PharmOut’s National GMP Forum page.

GMP Training Courses and cGMP and EU GMP Services Available including Audit Response Assistance and QMS templates

cgmp-training-courses-eu-gmp-requirements-1We 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, 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.

In addition to many Validation, Engineering and GMP training courses, we also share presentations from our past annual GMP Forums or more about our training events.

Not what you looking for go back to our GMP Training page