Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

21 & 22 November, 2022

In this training, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudralex Volume 4 Annex 11 guidelines.

Basic Principles of Computerized Systems Compliance Using GAMP® 5 Version 2 - EU edition MasterClass

In this training, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudralex Volume 4 Annex 11 guidelines.

 

21 & 22 November, 2022, Virtual

Time Zone: UTC/GMT+1 /CET

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Overview

 

With modern facilities, installations, and equipment, PLCs and computers are an integral part of such systems. More often than not PLCs and computers are considered autonomous systems and handled separately within the QMS and protocols. In this two-day course, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudralex Volume 4 Annex 11 guidelines.

#masterclass     #glceurope      #pharmaonlinetraining      #globalleadingconferences       #basicprinciplesofcomputerizedsystemcompliance      #GAMP5

 
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Who should attend imgRECOMMENDATION

Who should attend?


QA, QC, Validation Specialists, Engineers, Consultants, Contractors & Validation Service Providers, and Management who need a good understanding of Computer Systems Compliance and regulations

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

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10+

Years of experience

299

Events organized

3,410

Speakers

17,761

Attendees

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Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany