cfi Pharma Consulting

Our Services

Validation and Qualification

ERP System
MES System
BAS System
Serialization
Laboratory Integrated Management System
IT Infrastructure
Customize System
Quality Management System
GMP Equipment
Instrument Qualification
CSV Remediation Life Cycle

Quality and Management

Vendor selection
Validation and Qualification Process
Quality Management
Audit and Self Inspection
Workshop and Training
Data Integrity Issue

Development

Build System
Modification System
Integration System

Manpower

Validation Engineer
Qualification Engineer
Quality Personel
IT Engineer
IT Compliance
Database Engineer

Activities

Saturday, April 23, 2022

This document is one of simple document in Computer System Validation, but critical as we know the document is fundamental of th project and validation. Sometime problem faced by author, system owner and other personal confuse to :

Create a component of document (template).
Writing the requirement relate to Computerized System.
Adopt regulation point into document.
Ideal method to create URS document.

With online CSV training from us, We hope all of participant get a new knowledge and understand what is function of URS document in Computerized System Validation. Our facilitator have experience as CSV Engineer and Consultant for 9 years more in Pharmaceutical and Medical Device Industries.

Check it out our eFlyer for more details:

Friday, April 15, 2022

INHOUSE TRAINING AND WORKSHOP COMPUTERIZED SYSTEM VALIDATION by CFI

Training details :

The training consist of 1 day theory and 2 days practice. Reference of training following GAMP5 ; Computer System Validation, Data Integrity and CSV Regulation (CPOB, 21 CFR Part 11, Anex 11). Demo validation using actual system on customer site.

Duration : 3 days
Target Training :

Participant understand basic of CSV, Data Integrity and regulation.
Participant able to create CSV Document.

Target Participant from :

Quality Assurance
Quality Control
Information Technology
Engineering
Production
Warehouse

Capacity : 20 Seat
Free : Module and material, eCertificate, Tempate CSV, CSV consultation and document validation for demo.

Contact Us:

Click for WhatsApp chat

Fajar 081210452982

Edrick 081382589383

Email: cs@cfi.co.id

Web: www.cfi.co.id

Thursday, October 14, 2021

Registration Link: https://bit.ly/CSVlab-EMS

More information: 0812-1602-6828 / 0813-4555-6227

Wednesday, October 6, 2021

Proudly present our Data Integrity practitioner in Pharmaceutical industry Arnold Edrick. He will transfer knowledge regarding Baby step to implement CSV in Pharmaceutical and Medical Device Company. This event is FREE and you will get an e-certificate. Interested? Just click intip.in/csvwebinar . Thank You!