Compterized Systems Validation in Laboratory Equipment

Description of the Seminar

In this seminar;

  • FDA, EU Annex 11 requirements for Laboratory Equipment Validation / Quality Control Process
  • Category Approach and Validation Process in Laboratory Equipment,
  • Laboratory Equipment Validation Phases will be detailed with examples..

Aim of the Seminar

Following terms will be explained in this seminar:

  • Finding deficiencies on existing equipment for laboratory equipment validation effort
  • Categorizing Laboratory Equipment
    Categorizing Laboratory Equipment according to GAMP
    Categorizing Laboratory Equipment according to USP
  • Defining validation strategies for laboratory equipment and qualification efforts 
    Design Qualification
    Installation Qualification
    Operational Qualification 
    Performance Qualification
  • Documentation content necessary for laboratory equipment validation. Data integrity in laboratory equipment validation

Participant Profile

  • Laboratory technical personnel, lab analyst, Lab specialists in Pharmaceutical Industry
  • New employees in Quality Department in Pharmaceutical Industry
  • Laboratory Equipment Suppliers
  • Quality Assurance

Agenda

09:00 – 09:30 : Registration
09:30 – 10:00 : Meeting and Expectations from the Seminar
10:00 – 10:30 : Gap Analysis for Laboratory Equipment
10:30 – 11:00 : Break
11:00 – 13:00 : Designating Category Approach and Validation Process in Laboratory Equipment – Exemplary Studies
13:00 – 14:00 : Lunch
14:00 – 15:30 : Required documentation for the Laboratory Equipment Validation
15:30 – 16:00:  Break
16:00 – 16:30 : Legal Requirements
16:00 – 17:30 : Questions

Instructor

Sebnem Kesim MSc
Being consultant at Conval Group, Sebnem Kesim has nearly twelve years of experience in pharmaceutical industry. Before working as a consultant at Conval Group, she was working at Abdi İbrahim Pharmaceutical Quality Control Laboratories as an analyst. For 10 years in Conval Group, she participated in Laboratory Equipment Validation and Laboratory Computerized System projects. Şebnem Kesim is a chemical engineer, who completed her post graduate in “Engineering Management”.

Seminar Location and Registration

Seminar Location: Conval Grup Egitim Salonu
Kanlıca Mah. Hacı Muhittin Sok. No:35 Beykoz İstanbul

Seminar Registration:

Registration Price: 400 EU + KDV (Included in Price: Seminar documents, seminar certificate, lunch and tea/treat supply for all day)

Contact:  Yağmur Tuğrul - 0549 203 0496
seminar@convalgroup.com

Payment Info 
Account Name: CONVAL GRUP VALİDASYON EGİTİMİ VE DANISMANLIK TİC. LTD. STİ.
Bank: AKBANK
Branch: Gayrettepe (287)
TL IBAN: TR11 0004 6002 8788 8000 0762 87
EUR IBAN: TR92 0004 6002 8703 6000 2088 48