CBE - Centre for Biopharmaceutical Excellence

Overview

CBE GMP Uplift Programs will provide participants with a real-world perspective on Good Manufacturing Practice (GMP) and are designed to assist with the interpretation and application of GMP into practice, for those involved in human health products. CBE brings strong technical credentials, with experience across large and small Biologics, Pharmaceuticals and Regenerative Medicine companies, both in consulting and GMP related enterprise training.

This program is supported by MTPConnect’s $32 million Researcher Exchange and Development within Industry (REDI) initiative funded by the Medical Research Future Fund (MRFF). In delivering the REDI program, MTPConnect is partnering with research, training and industry organisations to deploy an integrated three-pillar plan driving skills and workforce development for the medical technology, biotechnology and pharmaceutical (MTP) sector nationally. Through a competitive process, MTPConnect has selected additional industry training providers to deliver new programs addressing key skills gaps in the sector workforce (REDI Brochure).

CBE will lead the Consortium, accompanied by ARCS Australia and Merck Life Sciences Australia; CBE Pure Solutions (VIC), Translational Research Institute TRI (QLD) and UTS Biologics Innovation Facility (BIF) (NSW) facilities are used for hands-on training in a GMP-like environment. The Programs will feature high calibre, relevant Guest Lecturer faculty to share real-world experiences.

CBE’s GMP Uplift Programs will provide participants with an industry relevant, practical and experiential GMP learning experience.

Essential GMP Program

The Essential GMP Program is designed for entry level employees (new starts up to 12 months) and is a 5-day equivalent course, designed for participant flexibility and to upskill in core GMP principles. It includes:

• The first modules build the theoretical concepts of a Core GMP framework for all students, covering the GMP basics. 6 Core GMP modules covering fundamental concepts of GMP delivered virtual online or facilitated for larger groups.
• Complementing this, participants will choose 2 Elective modules across Biologics, Pharmaceuticals, Regenerative Medicines and Quality Control delivered virtual and facilitated online or facilitated for larger groups.
• The final two days are onsite, face to face and cover a GMP Workshop of case studies and the application of theory into practice. The application of theory into practice with a GMP Hands-on Workshop in an experiential GMP environment.
  
• These are offered on scheduled days from Q3 2022 at either CBE Pure Solutions (VIC), TRI T3 Cleanrooms (QLD) or UTS Biologics Innovation Facility (BIF) (NSW).
• Program costs are covered under REDI, places are limited.

Advanced GMP Program

The Advanced GMP Program, is for those working in a GMP role (12 months+) looking for an in depth understanding of the critical areas that underpin GMP compliance in practice. It includes:

• 6 Advanced short courses, are complementary and for those wanting to upskill.
• Each course will utilise a theory session, case study to demonstrate theory in practice and facilitated workshop with Q&A to explore the learnings from the case study.
• Designed for busy professionals, the modules will have online components, with virtual facilitated sessions and will be scheduled from September 2022.
• Program costs are covered under REDI, with a small co-payment per participant.

All CBE programs will have live examples, case study work and assessments for certification, as well as guest lecturer content.

Click here to register for a place in the GMP Uplift Program or log in to the GMP Uplift LMS

GMP Uplift Consortia

Essential GMP Uplift

Training for Entry Level Employees

CBE consultants have worked in industry and consulted for decades within evolving GMP environments. This background has enabled us to have a clear vision of what is needed for entry level employees. We understand that, without context, the GMP rule can be confusing and seem somewhat arbitrary. This is the reason for Core GMPs, which are technology independent and provide fundamentals of why, what and how GMP rules are applied in different work functions and cover universal requirements/GMP principles. The Core GMP Modules will be online, have an assessment and are a pre-requisite for the Electives and Workshops. Prior to entry into the course participants will be required to pre-read resource information.

The four Electives are more specific GMPs tailored to each of three technologies plus laboratory Quality Control and provide GMP expectations within different technologies. Participants complete two Electives, allowing them to stream to technology GMP modules that that relate to their workplace and have more specific examples, case studies and guest lecturers. The Electives will be virtual, on-line, facilitator lead and have an assessment.

On the completion of the six Core and two Elective GMP Modules, students will do the two workshops are designed for students to apply their GMP learnings. A one-day, face-to-face facilitator led, onsite Case GMP Workshop for feedback, problem sharing, group practice using case work, an opportunity to engage in Q&A and networking.

The last day enables the participants to apply in practice within a facility in a “hands on” learning environment. The experiential Hands-on GMP Workshop will familiarise participants with working in an industrial environment where they can practice GMP related activities. The simulated environments for the training are either TRI T3 Cleanrooms Brisbane, Queensland, UTS Biologics Innovation Facility (BIF) Sydney, NSW and CBE Pure Solutions, Melbourne, Victoria. The facilities can accommodate 8 - 12 participants for the on-site training. These may also be conducted at the client premises by agreement.

Each module will an have assessment and at completion of the Essential GMP Uplift Program participants will receive a Certificate and a certified digital credential badge for students to use and record their education history in their professional history. As an outcome by the end of the training program, attendees will have broad understanding of GMP principles, quote specific examples, understand basic GMP application in case studies and have practical hands-on experience of base concepts to operate entry level tasks in a GMP environment.

Essential GMP Program Outline

Course
CORE GMP 1 Introduction to GMPs, Regulations and Licensing	International GMPs and Regulatory Bodies GMP license and how they are obtained Tour of the cGMP and Annexes – finding rules Relationship between GMP rules, employee behaviour and patient safety
CORE GMP 2 Quality Assurance	Role of the Quality unit Pharmaceutical Quality Systems and key elements How and where Quality Control is applied Quality Assurance and the Supply Chain Release of products to market
CORE GMP 3 GMP Documentation and Records	Importance of documentation – SOPs and Records​ Importance of the Master Batch Records and Specifications​ Rules for accurately completing GMP records ​ What does my signature mean Introduction to Data Integrity
CORE GMP 4 Facilities, Cleanrooms, Materials and Equipment Controls	Principles of design and control for Facilities, Cleanrooms and Equipment Design and operational considerations for Facilities, and Cleanrooms Facility design, personnel and materials flow for different examples of manufacturing processes Materials storage and management Operation, maintenance and qualification
CORE GMP 5 Production and Contamination Control	What do cGMPs inform about production and contamination control Process flows for Pharmaceuticals Process flows for Sterile Products and Biologics Where does contamination originate and how to prevent it Importance of cleaning and sanitation
CORE GMP 6 Quality Control	Importance of Quality Control and Good Laboratory Practices (GLP’s) Good documentation practice within Laboratories Requirements for Analytical Laboratories Requirements for Microbiology Laboratories Working with Production
Elective 1 Biologics	Introduction to Biologics​ Biologics upstream and low bioburden processing​ Downstream purification processing steps ​ Aseptic Filling and Packaging​ Special contamination controls for Biologics​
Elective 2 Pharmaceuticals	Different types of Pharmaceutical dose forms Unit Operations and their CPPs and CQAs In-process controls and introduction to Control Charts GMPs and controls for Oral Solid Dose (OSD) GMPs and controls for Liquids and Creams (Topicals) A typical batch record for a Pharmaceutical Product
Elective 3 Regenerative Medicine & Sterile	Introduction to Regenerative Medicines technology What does Sterility Assurance mean to manufacturers and patients Controls for sterile manufacture and potential contamination sources Open and closed processing systems Introduction to Regenerative Medicines technology Regenerative Medicine production processes and quality control The role of people in keeping patients safe
Elective 4 Advanced Quality Control	Role of the Quality Control Unit Understanding pharmacopeias Criticality of test records and data integrity Test Method Validation
Case Workshop	GMP Case Study Workshop The practical workshop will review concepts, discuss GMP interpretations and practice using an industry case study The case study is used to illustrate the interpretation of the cGMPs in a simulated compliance situation and will have an assessment
Hands-On Workshop	GMP Hands-On Experiential Training in Facility The objective of the day is to reinforce and practice the concepts raised during the program It will cover activities such as gowning, working aseptically, environmental monitoring, laboratory testing

The program has been designed to be agile and for flexibility, it can be run via online, webinars and virtual facilitation or “in-house” at company locations face-to face or a combination by arrangement with the client. Working with REDI and the industry around needs, CBE will offer companies the option depending on trainee numbers, external environment and feedback received.

The program costs are covered by MTPConnect REDI Initiative for companies and participants eligible for the Essential GMP Program for a limited number of complementary places.

Essential GMP Program Schedule

The published schedule for the 2023 Essential GMP Program for REDI supported places is available. Places per cohort are limited, so register your interest today to secure a place or email gmpuplift@cbe-ap.com.au.

2023 Schedule

Cohorts	Course Opens & Essentials Program Welcome and Information Session	Elective Q&A Sessions~	Workshop Site	GMP Case Study Workshop	GMP Hands-On Workshop	GMP Hands-On Workshop	Status>
January 2023 Summer Intensive 2	16th January 2023	10th February 2023	CBE CBEPS VIC	22nd February 2023 (CBE)	23rd February 2023 Group 1	24th February 2023 Group 2*	Enrolments Closed Graduation April 2023
March 2023	27th February 2023	20th March 2023	TRI QLD	29th March 2023	30th March 2023 Group 1	31st March 2023 Group 2*	Enrolments Closed Graduation June 2023
March 2023	27th February 2023	20th March 2023	UTS NSW	13th April 2023	14th April 2023		Enrolments Closed Graduation June 2023
May 2023	24th April 2023	19th May 2023	CBE CBEPS VIC	24th May 2023 29th May 2023 (CBE)	25th May 2023 Group 1	26th May 2023 Group 2*	Enrolments Closed Graduation July 2023
June 2023	24th April 2023	19th May 2023	TRI QLD	1st June 2023	2nd June 2023		Enrolments Closed Graduation July 2023
June 2023	29th May 2023	23rd June 2023/ 4th August 2023/ 19th September 2023	UTS NSW	28th June 2023	29th June 2023		Enrolments Closed
July 2023	18th July 2023	4th August 2023/ 19th September 2023/ 21st November 2023	CBE CBEPS VIC	10th August 2023 (CBE)	11th August 2023 (CBEPS)		Enrolments Closed
August 2023	18th July 2023	4th August 2023/ 19th September 2023/ 21st November 2023	TRI QLD	24th August 2023	25th August 2023		Enrolments Closed
September 2023	18th July 2023	4th August 2023/ 19th September 2023/ 21st November 2023	UTS NSW	14th September 2023	15th September 2023		Enrolments Closed
October 2023	22nd August 2023	19th September 2023/ 21st November 2023	CBEPS VIC	23rd November 2023	24th November 2023		Enrolments Closed
November 2023	12th September 2023	19th September 2023/ 21st November 2023	SA^	27th November 2023	28th November 2023		Enrolments Closed
November 2023	31st October 2023	21st November 2023	WA	30th November 2023	1st December 2023	8th December 2023	Enrolments open

~Webinar Sessions, one for each Elective, including Elective 01 Biologics, Elective 02 Pharmaceuticals, Elective 03 Regenerative Medicines & Sterile Products, Elective 04 Advanced Quality Control

*Availability subject to cohort numbers

^By arrangement ^>Graduation date is subject to completion of the 6 Core modules, 2 Elective modules and 2 Workshops

Click here to register for a place in the GMP Uplift Program

Case Studies

With participants from more than 85 companies having completed in the GMP Uplift Essentials programs so far, there are many examples of where upskilling

• UNSW RNA Institute - GMP training uplifts RNA Institute, case study here
• EnGenIc - From nanotech breakthroughs to GMP excellence: EnGeneIC’s quest to transform cancer treatment, case study here

Learning Management System (LMS)

GMP Uplift course material is available via the LMS, once your registration has been approved, students can access the LMS. Click here to log into the GMP Uplift Learning Management System.

Advanced GMP Uplift

Training for those Experienced in GMP, up to Senior Level Managers

Current GMP requirements are increasingly demanding and complex and getting it right first time has significant impacts on quality, regulatory compliance and business efficiency. Modern managers need to understand and work across different disciplines as part of a cohesive team. The six short courses are based on consultation with industry and our consulting experience where we often see knowledge gaps and sub-optimal application of these disciplines. In particular, the application of risk management has significant leverage over the other five topics and will be a common theme throughout the series.

Advanced GMP Program Outline

The six courses are complementary and designed to super charge attendees for a more in depth understanding of critical areas that underpin GMP compliance in practice.

Short Courses
Risk Management	Risk is a foundational concept, that can be applied to all other areas of Quality Management. This course will cover the expectations of Quality Risk Management (QRM) in the MTP sector. Participants will learn to identify and apply the processes of QRM, the qualitative and quantitative tools to assess risk and classify risk into classes and different applications for reactive vs proactive situations. As well as how to organise, facilitate and participate in effective risk assessments and constructing risk management reports.
Investigations and Root Cause Analysis	Investigations and Root Cause Analysis (RCA) are vital tools for effective Corrective and Preventative Actions (CAPA) and Change management. This course covers problem investigations, RCA, CAPA and Change management, where participants will learn to identify key process steps for effective investigations, defining problems, investigation plans. Participants will learn the difference between symptoms and root causes, the application of QRM to determine actions, CAPA and continuous improvement via change management.
Validation	The language and terminology of qualification and validation can be very confusing, complex and easily misunderstood. This course explains correct terminology, introduces participants to industry requirements for qualification and validation, as well as how to determine a “validated state”. It will give participants practical knowledge in the interpretation of validation requirements, to manage validation programmes and prepare documentation aligned with the GMPs. It covers qualification sequences, equipment assessments, cleaning limits, CCPs and CQAs and process controls.
Aseptic Practices	Aseptic processing and the GMP rules are particularly complex and require expert interpretation and application. This course will provide an overview of many of the GMP rules for aseptic processing and enable participants to interpret Annex 1 requirements, as well as manage the risks associated with aseptic processes. Participants will gain an appreciation of the expectations for compliance when manufacturing sterile products, including media fills, clean room classifications, particulate monitoring, microbial monitoring and interpretation of environmental monitoring trends.
Audit Readiness	Managing a regulatory inspection is critical to successfully maintaining GMP compliance or obtaining a GMP License. It is evident that a well prepared site has a much higher chance of success than one that is not prepared.  Regulatory inspection can be stressful for all parties and everyone wants a balanced and fair outcome. This course explains what is expected from a regulatory inspection, how to apply the 4Ps approach and how to facilitate the right outcome from an inspection. Participants will learn how to be audit ready, prepare for an inspection, how interviews should be conducted and how to deal with any non-conformances.
Advanced QMS	Quality Management is considered the most important GMP system and as such the functioning of the Quality Management System (QMS) is central during regulatory inspections. A QMS consists of 10 fundamental elements and this course explains the process flows for most these elements.  ICH Q10 now includes a continuous improvement requirement within the quality system and this is covered in the context of change management, quality metrics, auditing and management reviews.

Delivered in a virtual, online environment, ideal for busy professionals. Theoretical concepts will be translated to the real world environment and be supported with Guest lectures, self directed learning, Q&A facilitated sessions and case work. A minimum of 12 months working in a GMP role or the GMP Essentials Program are pre-requisites for the course.

There is an online Welcome and Information Session, then each online Short Course will entail:

• Two to three hours of theory, practical application and guest lectures (self paced learning)
• One hour of facilitated Q&A Session with a CBE expert
  
• Case study work
• An online Assessment
  

Each Short Course will have an assessment and at completion of the Advanced GMP Uplift Program participants will receive a Certificate.

Advanced GMP Program Schedule

The schedule for the 2024 Advanced GMP Program is now available, Please contact CBE to inquire about registration (individual or company). Places per cohort are limited, so register your interest today to secure a place or email gmpuplift@cbe-ap.com.au with any queries.

2024 Schedule

Cohort	Course Opens & Welcome Information Session	Advanced Module 1/2		Advanced Module 3/4		Advanced Module 5/6		Status
Q1 2023	30th January 2023	6th February 2023	13th February 2023	20th February 2023	27th February 2023	5th March 2023	12th March 2023	Enrolments open
Q2 2023	TBC							Expression of interest open

Click here to register for a place in the GMP Uplift Program

Learning Management System (LMS)

GMP Uplift course material is available via the LMS, once your registration has been approved, students can access the LMS. Click here to log into the GMP Uplift Learning Management System.