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Process Validation & Technology Transfer

Process Validation Protocol

Process Validation & Technology Transfer Event Date 22 – 23 April 2019, Location: Vienna, Austria

MASTERCLASS OVERVIEW OF PROCESS VALIDATION TRAINING

This unique two-day interactive course is designed to provide insight how Quality by Design, state-ofthe-art Technology Transfer and modern Process Validation are tied together.The regulatory background and requirements will be explained, and case studies and workshop exercises will help you understand on how to best translate theory into practice and overcome frequently faced challenges.Although the focus of the course is on smallmolecules and solid dosage formulations many of the techniques and approaches discussed will be applicable for biological molecules and other dosage forms as well.

Key Topics Technology Transfer Process Validation Training

  • In this training participants will learn about new Guidance and Requirements for Process Validation
  • In this training participants will understand process Design Stage: Key input for Product and Process Quality
  • In this training participants will learn Process Performance Qualification
  • In this training participants will learn about Continued Process Verification
  • In this training participants will witness Technology Transfer
  • In this training participants will understand Risk Assessment & Control Strategy Tools

Who should attend Technology Transfer Process Masterclass?

  • Pharmaceutical Technologists should attend this masterclass
  • Process Scientists and Process Engineers should attend this masterclass
  • Process Validation Specialist should attend this masterclass
  • Quality Assurance should attend this masterclass
  • Technology Transfer should attend this masterclass
  • Project Managers should attend this masterclass
  • CMO Managers should attend this masterclass

Key Takeaways of Technology Transfer Consulting Workshop

Understand

  • Industry approaches for Technology Transfer and Process Validation applying QbD principles
  • Risk assessment methodologies (FMEA vs Process Risk Map)

Learn

  • IAn outline of proven best practice in process validation and technology transfer
  • About Process performance qualification and Continued process verificatio

Gain

  • Regulatory insights and guidance (EU & FDA) how to perform Technology Transfers and Process Validation.
  • Practical knowledge and tools during two interactive sessions and workshops

Registration Fee


€2496


Per Participant


About Vienna, Austria

Vienna, Austria’s capital, lies in the country’s east on the Danube River. Its artistic and intellectual legacy was shaped by residents including Mozart, Beethoven and Sigmund Freud.

Start Time

9:00 am

April 22, 2019

Finish Time

5:00 pm

April 23, 2019

Address

Vienna, Austria

Our Facilitator