Description

This 90-minute webinar, Pharmaceutical Technology: Practical Application of Technology Transfer, provides a comprehensive, real-world overview of the technology transfer (TT) process within the pharmaceutical manufacturing lifecycle. Participants will explore the foundational purpose of TT—ensuring consistent, large-scale production of high-quality products by transferring critical knowledge, processes, formulations, and analytical methods from R&D to manufacturing. The session breaks down each phase of the TT process, including project planning, documentation development, process and method validation, and the importance of detailed protocols and reports. Emphasis is placed on integrating quality assurance measures throughout, guided by regulatory expectations such as GMP compliance and ICH guidelines (Q8–Q12).

One major focus of the webinar is the human element: the importance of training personnel and developing robust, site-specific technical SOPs to ensure a successful and compliant transfer. Real-world challenges—like site variability, scale-up issues, knowledge gaps, and global regulatory hurdles—are explored alongside risk mitigation strategies and industry best practices. The session includes an interactive poll, case study, and Q&A segment to foster engagement and provide practical insight. By the end of the webinar, attendees will be equipped with the knowledge and tools to plan, execute, and document an effective pharmaceutical technology transfer that maintains product quality, regulatory compliance, and operational continuity.

Learning Objectives:-

• Understand the key phases, documentation, and regulatory expectations involved in pharmaceutical technology transfer.
• Identify common challenges in technology transfer and apply risk-based strategies to mitigate them.
• Develop effective training plans and technical SOPs to support successful knowledge and process transfer.
• Apply best practices to ensure consistent product quality and compliance during scale-up and site-to-site transfers.

Areas Covered in the Session:-

I. Welcome and Objectives (5 minutes)

• Speaker introduction
• Overview of session goals:
  • Understand the purpose and phases of technology transfer (TT)
  • Learn the importance of documentation, training, and QA
  • Review regulatory expectations and common pitfalls
  • Explore real-world applications through case examples

II. Purpose and Scope of Technology Transfer (10 minutes)

• Ensuring large-scale manufacturing consistency
• Transferring knowledge from R&D to production
• Movement of:
  • Formulations and processes
  • Analytical methods
  • Quality assurance techniques
• Role in maintaining product quality and regulatory compliance

III. Key Phases of the Technology Transfer Process (20 minutes)

• 1. Planning and Initiation
  • Define scope and teams
  • Draft a Technology Transfer Protocol (step-by-step TT plan)
• 2. Knowledge and Process Transfer
  • Data packages: process descriptions, CQAs, CPPs
  • Integration of analytical methods into production
• 3. Validation Activities
  • Process, cleaning, and method validation
  • Demonstrating consistency and reproducibility
• 4. Documentation and Reporting
  • Batch records, validation protocols, TT reports
  • Regulatory filing support

IV. Training and SOP Development (10 minutes)

• Importance of training personnel on new processes and equipment
• Developing or revising technical SOPs tailored to receiving site
• Conducting competency assessments to ensure readiness
• Use of hands-on simulations, classroom, and digital LMS tool

V. Regulatory Considerations and Compliance (10 minutes)

• GMP compliance as a foundation of TT
• Alignment with ICH guidelines (Q8–Q12)
• Emphasis on traceability through complete documentation
• Evaluate transfer impact on product quality and safety

VI. Common Challenges in Technology Transfer (10 minutes)

• Site variability: equipment and environment differences
• Scale-up issues: deviations during commercial batch production
• Knowledge gaps: incomplete or misaligned communication
• Regulatory complexity: varying requirements globally
• Risk mitigation with cross-functional collaboration and gap analysis

VII. Case Study: Technology Transfer in Action (10 minutes)

• Transfer of a formulation and process from R&D to manufacturing
• Key activities:
  • Protocol execution
  • Training implementation
  • QA and validation checkpoints
• Lessons learned from overcoming real-world scale-up and QA hurdles

VIII. Best Practices and Tools for Effective Transfer (5 minutes)

• Start early with a defined TT protocol
• Align on documentation, SOPs, and training
• Maintain clear communication across departments and sites
• Use digital tools (LMS, documentation platforms, TT tracking systems)

IX. Final Q&A and Wrap-Up (5 minutes)

• Recap key points
• Answer final questions
• Share resources (guidelines, checklists, references)
• Invite feedback and provide contact for follow-up.

Background:-

Technology transfer is a critical component of the pharmaceutical product lifecycle, serving as the bridge between research and development (R&D) and full-scale commercial manufacturing. As products progress from the lab to production, ensuring that formulations, processes, and analytical methods are accurately and consistently transferred is essential for maintaining product quality, safety, and regulatory compliance. However, the transfer process often involves complex challenges, such as differences in equipment, scale-up issues, site variability, and regulatory requirements across regions.

With increasing reliance on global supply chains and contract manufacturing organizations (CMOs), the demand for well-planned and thoroughly executed technology transfer has never been greater. This training addresses these complexities by offering participants a structured approach and practical tools to navigate each phase of the technology transfer process.

Why You Should Attend:-

This training is essential for professionals involved in pharmaceutical manufacturing, quality assurance, regulatory affairs, R&D, and technology transfer because it bridges the gap between development and commercial production—an area where missteps can lead to costly delays, compliance risks, and product failures.

Participants will gain practical insights into executing a seamless technology transfer, including how to manage documentation, ensure regulatory alignment, and train staff effectively. By attending, they will enhance their ability to lead or support transfer activities with confidence, ensuring consistent product quality, operational efficiency, and successful regulatory outcomes in both internal and outsourced manufacturing settings.

Who Should Attend:-

• Research & Development (R&D)
• Process Development
• Manufacturing / Production
• Quality Assurance (QA)
• Quality Control (QC)
• Regulatory Affairs
• Technology Transfer Teams / Specialists
• Project Management
• Training and Learning & Development (L&D)
• Engineering and Technical Services
• Supply Chain / Technical Operations.