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.
CPD Hours: 12
Course Content
- Day 1
- Day 1: Foundations and regulatory framework
- Module 1: Introduction of technology transfer
- Module 2: Global regulatory expectations
- Module 3: Quality by design and risk management
- Module 4: Planning and management of tech transfer project
- Exercise 1: Design a tech transfer plan
- Module 5: Transfer documentation & knowledge management
- Exercise 2: Create a transfer protocol
- Module 6: Regulatory and GMP compliance in transfers
- Day 2
- Day 2: Execution, analytical transfer and lifecycle management
- Module 7: Process execution at the receiving unit
- Module 8: Facility, equipment, and material adaptation
- Module 9: Analytical method transfer (AMT)
- Exercise 3: Analytical method transfer protocol creation
- Module 10: Training, knowledge transfer and troubleshooting
- Module 11: Post-transfer regulatory and lifecycle management
- Module 12: Case studies and emerging trends
Speakers
Aneta Jell
Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience
across manufacturing, contract operations, and quality leadership in the pharmaceutical
industry. Currently serving as Quality and training manager at PaulPalmer limited she
oversees global contract manufacturing quality, ensuring GxP compliance, regulatory
alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and
QMS administration, with proven strength in audits, CAPA, deviations, and technical
agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak,
Aneta is recognised for driving continuous improvement, fostering compliance culture, and
leading high-performing quality and HSE teams.
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
Who Should Attend
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
