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 3. GAMP® 5 and Basic Principles of Computerized Systems Validation Webinar

 * All,
 * Pharmaceutical & Biotechnology,


GAMP® 5 AND BASIC PRINCIPLES OF COMPUTERIZED SYSTEMS VALIDATION WEBINAR

May 23, 2023 Europe
Expired

REGISTRATION DEADLINE EXPIRED!!


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


EUR499

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



22/30

SECURE YOUR SEAT

REGISTER NOW




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.

 


 * 23 May First Day
 * 24 May Second Day

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
 * Venue : Europe


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speakers, innovation topics and   interactive programs.

    


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