Course overview

As global operations grow more complex and outsourcing and accelerated launches become common, robust technology transfer process is essential to ensure product quality and supply continuity.

This two-day training course provides a comprehensive understanding of technology transfer, aligned with international regulatory guidelines ((FDA, EMA, MHRA, WHO, ANVISA, ICH Q7-Q12, EU GMP Annex 15, WHO TT guidance) and current industry expectations.

Participants will learn how to plan, execute, and manage technology transfer activities using science and risk-based methodologies. and how TT fits within the product lifecycle and the PQMS. It integrates current hot topics - such as digitalization (Pharma 4.0 tools), data integrity, and advanced regulatory frameworks - into the foundational principles of effective tech transfer.

Emphasis will be placed on the co-ordination between Sending and Receiving Units, addressing facility and equipment differences, and integrating Quality by Design (QbD) and Quality Risk Management( QRM) principles into transfer strategies.

Participants will also learn how to create transfer protocols, perform detailed gap analyses, use knowledge transfer practices, and regulatory-aligned documentation to ensure GMP compliance throughout.

The course includes Analytical Method Transfer and is designed to support a variety of operational models including small molecules, biologics, combination products, and outsourced manufacturing and as a result provides a practical framework for executing reliable, compliant transfers across diverse settings.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Understand the lifecycle context of Tech Transfer and how it supports product development and quality systems
Apply risk-based, science-driven principles to build transfer strategies based on data and risk assessment
Improve cross-site collaboration and engage effectively between Sending and Receiving Units.
Master analytical method transfer to ensure analytical methods are successfully transferred and performed at the new site
Identify and mitigate common pitfalls through addressing issues like scale-up, equipment gaps, or knowledge loss early
Apply regulatory expectations according to FDA, EMA, ICH, and WHO requirements
Strengthen governance and knowledge management with the use of structured oversight and tools to manage documentation and decisions
Learn from real-world case studies in practical sessions from successful transfer projects across product types

Who should attend

This course is designed for professionals involved in developing, transferring, or manufacturing pharmaceutical and biopharmaceutical products including:

Technology Transfer teams or MS&T (Manufacturing Science & Technology) professionals
Production managers and Engineers
R&D scientists and formulators
Quality Assurance and Quality Control managers
Regulatory Affairs specialists
CMC Project managers
Analytical Development scientists
Supply Chain and Outsourcing/CMO Management specialists

Enrol/reserve

This course will cover:

Day 1
Day 2

Day 1: Foundations and regulatory framework

Module 1: Introduction of technology transfer

The Role of Pharmaceutical Quality System (ICH Q10)
Digital Tools and Pharma 4.0™ Principles
Digital twins (virtual process models) and remote transfers

Module 2: Global regulatory expectations

FDA, EU GMP Annex 15, WHO Technology Transfer Guidelines
ICH Q8, ICH Q9, ICH Q10, ICH Q11 and ICH Q12
Regional Regulatory Compliance

Module 3: Quality by design and risk management

QTPP,CQAs and CPPs
TT linkage to QbD
Integration of New updates of ICH Q9 (R1)

Module 4: Planning and management of tech transfer project

Cross-functional Tech Transfer team roles (SU vs RU)
Gap Analysis & Due Diligence
Project transfer milestones, Governance & Communication

Exercise 1: Design a tech transfer plan

Module 5: Transfer documentation & knowledge management

Transfer plans, protocols, reports
Tacit Knowledge management
Data Integrity & Cybersecurity

Exercise 2: Create a transfer protocol

Module 6: Regulatory and GMP compliance in transfers

Change management & PACMPs
Regulatory Filing Strategy
GMP controls and inspection readiness

Day 2: Execution, analytical transfer and lifecycle management

Module 7: Process execution at the receiving unit

Engineering runs and PPQ
Scaling strategies and comparability
Data monitoring and continued verification

Module 8: Facility, equipment, and material adaptation

Equipment and facility
Utilities and Environmental considerations
Bridging studies and utilities qualification

Module 9: Analytical method transfer (AMT)

AMT protocol design
Alignment with new ICH Q2 and USP <1224>
Mitigation of OOS and lab variability

Exercise 3: Analytical method transfer protocol creation

Module 10: Training, knowledge transfer and troubleshooting

RU training strategies and knowledge continuity
Problem-solving and root cause analysis

Module 11: Post-transfer regulatory and lifecycle management

Regulatory Submission for Site Change
Post Approval Change Management Protocol (PACMP)
Continuous verification process

Module 12: Case studies and emerging trends

Enrol/reserve

Paul Palmer
Paul R Palmer Ltd

Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.

Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.

People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.

Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

8-9 June 2026

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 16899

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 04 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

8-9 December 2026

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 16900

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 03 Nov

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.