Process Validation Online Event

Event Details
  • Days
    Hours
    Min
    Sec
  • Start Date
    18 May 2026 12:00
  • End Date
    19 May 2026 15:00
  • Door Time
    11:55
  • Status
    Upcoming
  • Location
Digital Transformation Advisor
eLife Sciences
Senior Validation Specialist & AI Validation Expert
eLife Sciences
Senior Validation Lead, MSAT
Novartis AG
Strategic Product Manager
Skan AG
Principal Process Validation Consultant
ValSource Inc.

The webinar will provide a practical overview of validation across the full process lifecycle, from process design and qualification through continued process verification. Key topics include process characterization and the data-driven identification of critical quality attributes and critical process parameters, as well as the definition and implementation of a robust control strategy integrating process, equipment, sanitization controls, and advanced data analytics. The program will also address the use of AI-supported tools for trend analysis, anomaly detection, and enhanced process understanding, alongside sanitization validation and data requirements to demonstrate effective microbial control under worst-case conditions. The session will conclude with continued process verification and trending to ensure the process remains validated during routine manufacturing.

Webinar focus areas:

  • Validation of the process lifecycle covering design, qualification, and ongoing verification.
  • Process characterization and data-driven identification of critical quality attributes and process parameters.
  • Definition and implementation of a robust control strategy for process, equipment, and sanitization.
  • Use of AI and advanced analytics to support process understanding, trend evaluation, and early risk detection
  • Validation of sanitization and data support for effective microbial control under worst-case conditions.
  • Continued process verification and trending to confirm the process remains validated.

    Who Should Attend:

    Quality Assurance and Quality Systems professionals
    Manufacturing and Operations staff
    MS&T / Process Development and Process Engineering teams
    Validation, Qualification, and Technical Services personnel
    Microbiology and Environmental Monitoring teams
    Regulatory Affairs and Compliance professionals
    Site leadership responsible for GMP readiness and inspections

  • Qualification Tasks
  • How to develop a good decontamination cycle
  • How to keep the decontamination cycle during the lifecycle of the isolator

  • Refresh your beverage and recharge

  • Key global guidelines and expectations
  • PV strategy: number of batches, site/equipment representativeness, bracketing, worst-case conditions
  • Example of a successful lifecycle validation approach, including regulatory experience

  • Regulatory guidance for process validation
  • Risk-based approach to process validation
  • Equipment qualification requirements
  • What does the science-based approach mean?
  • Process validation lifecycle concept

  • Original price was: €159.Current price is: €99.
    Full Access
  • Full online access
  • Post-event documentation
  • Certificate of attendance
  • Leave a Comment

    Event Details
    • Days
      Hours
      Min
      Sec
    • Start Date
      18 May 2026 12:00
    • End Date
      19 May 2026 15:00
    • Door Time
      11:55
    • Status
      Upcoming
    • Location
    Sponsors