Equipment Qualification Training

Description of the Seminar

In this Seminar;

  • FDA and EU Annex 11 Requirements for Equipment Qualification
  • Defining Applied Equipment Qualification
  • Providing detailed information regarding Qualification Phases

Aim of the Seminar

Below listed concepts will be detailed in the Seminar:

  • Applied Equipment Qualification Definition
  • Qualification Phases 
  • Design Qualification 
  • İnstallation Qualification
  • Operational Qualification 
  • Performance Qualification
  • Operational Qualification
  • Data Integrity Applications on Equipment
  • FDA Warning Letter Exemples

Participant Profile

  • New Employees to Qualification and or Engineering Departments in Pharmaceutical Industry
  • New Employees to Validation/Qualification Departments in Pharmaceutical Industry
  • New Employees to Production Department in Pharmaceutical Industry
  • Equipment Suppliers
  • Quality Assurance

Agenda

 09:00 – 09:30  :Registration
 09:30 – 10:00  :Meeting - Expectations from the Seminar
 10:00 – 10:30  :Definition of Qualification
 10:30 – 11:00  :Break
 11:00 – 11:30  :Qualification Phases (Design Qalification –DQ)
 11:30 – 12:00  :Qualification Phases (Installation Qualification-IQ)
 12:00 – 12:30  :Qualification Phases (Operational Qualification-OQ and PQ)
 12:30 – 13:30  :Lunch
13:30 – 14:00  :Design Qualification Example Study –DQ
14:00 – 14:30  :Installation Qualification Example Study
14:30 – 15:00  :Break
15:00 – 16:00  :Operation Qualification Example Study
16:00 – 16:30  :Data Integrity
16:30 – 17:00  :Questions

 

Instructor

Banu Refik BSc, MBA

Banu Refik has twenty years of professional experience in Project Quality Management and Validation Consulting. She has a Chemical Engineering, Bio-Sciences degree with Cum Laude honors from NCSU and has an executive MBA from Boğaziçi University.

Senem Gungor, MSc

Being consultant at Conval Group, Senem Gungor has nearly five years of experience. Within this five year she has participated in projects such as Equipment, Infrastructure Systems and HVAC Systems. She has completed her undergraduate at Istanbul University in Chemistry Program and her post graduate on Chemical Engineering “Basic Processing and Thermodynamic” program.

Seminar Location and Registration

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

Seminar Registration:

Registration Price: 350 EU + KDV (Included in Price: Seminar documents, seminar certificate, lunch and tea/treat supply for all day)

Contact: Elvan Çimen- (0 544 290 98 13) elvan.cimen@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