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GAMP® 5 and Basic Principles of Computerized Systems Validation Webinar

Description

Computerized systems are a central point for determining and sequencing work processes in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity to validate all computerized systems which can influence the quality of pharmaceutical products and ensure compliance.
The foundation of the Training will be the current requirements for the validation of computerized systems like GAMP® and their GxP relevant application in practice.

Why you should attend this training?

  • You will be introduced to the basic principles and methods of the validation of computerized systems (according to GAMP®)
  • You will learn needed skills to plan, implement and document effectively validation activities for computerized systems and to assess them according to their GxP compliance
  • In  interactive sessions you can see how the theoretical foundations will apply in real-life situations
GAMP® 5  EVENT - EARLY BIRD TICKET

GAMP® 5 EVENT - EARLY BIRD TICKET

EUR499

Livestreaming Zoom _____ ✔️ Interactive Lectures _____ ✔️ FREE Recorded Webinar One Month Access _____ ✔️

22/30

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GAMP® 5  EVENT - EARLY BIRD TICKET

Who should attend?

This Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and validation of computerized systems.

  • Quality Assurance and Quality Control specialists
  • Validation specialists
  • Manufacturing supervisors
  • Technical and IT support personnel
  • Productions and Maintenance Engineers
  • All levels of management who need better general understanding of Computer systems validation and Compliance

About the trainer

Milos Nikolic – IT Director

Milos Nikolic

IT expert with over 20 years of experience in multinational companies on leadership and executive positions working on digital, innovation and business transformations by applying cutting-edge IT technologies and process optimizations.

 

8:45 am - 9:00 am Online

Connecting to Webinar

9:00 am - 9:45 am Online

Why we need GAMP5 and its purpose

Ensuring Compliance and Quality Control: GAMP5 (Good Automated Manufacturing Practice) provides guidelines and recommendations for the development and validation of automated systems used in the pharmaceutical and biotechnology industries.

9:50 am - 10:35 am Online

Computer System vs Computerized System

- Scope and Functionality - Hardware and software - User interaction

10:35 am - 10:50 am Online

Coffee Break

10:50 am - 11:55 am

Good Practice: Where to Start?

- Understand the GAMP guidelines - Identify critical systems - Establish validation procedures

12:00 pm - 1:00 pm Online

Q&A

- Q&A session with trainer

8:45 am - 9:00 am Online

Connecting to the webinar

9:00 am - 9:45 am Online

Risk Assessment – an evaluation of the threat to quality

- The identification, analysis, and evaluation of risks to product quality -Hazard identification, risk analysis, risk evaluation, and risk treatment

9:45 am - 10:00 am Online

Coffee break

10:00 am - 10:50 am Online

Supplier Documentation - reduction in duplication, inaccuracy and efforts

- Reduction in duplication - Reduction in inaccuracy - Reduction in efforts in GAMP

10:55 am - 11:40 am Online

Change and Configuration Management - the mechanism to STAY validated

- CCM implementing, documenting, testing and validation

11:40 am - 11:55 am Online

Coffee break

11:55 am - 12:30 pm Online

Business benefits

12:35 pm - 1:30 pm Online

QA

Q&A session with trainer

  • Date : May 23, 2023 - May 24, 2023
  • Time : 9:00 am - 1:00 pm (UTC+0)
  • Reg. Deadline : May 17, 2023 12:00 am
  • Venue : Europe

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