A 2 Day Course on

6 - 7 MAY 2019 | 7 - 8 OCTOBER 2019 . Jasmine Room, N22, IBD UTM

course introductionNowadays, biopharmaceutical business is fast growing sector worldwide. The market of biopharmaceuticals, excluding tissue engineering products, will exceed 85 US$ Billions by 2020. The production process of these types of product should be carried out according to the current Good Manufacturing Practices (cGMP) guidelines. This course will gives complete overview about the production facility from the start of the project up to the production process and how to carry out all projects steps according to the guidelines of the cGMP. Topics will include: the primary and details engineering in the production area, flow inside facility (Personnel, material, product and waste flow), the design of HVAC system and clean area according to the cGMP requirements for the production of equipment, from cell bank to final product. Furthermore non-design/equipment components of the cGMP such as human resource, process design and operation procedure based on Standard Operating Procedures (SOPs) sheet will be presented.

The course aims to:

• Provide information about the difference types of biopharmaceutical factories and how to start to build facility according to the cGMP requirements.

• Provide information about the basic engineering requirement for the building and how to design it to fulfil the cGMP requirements concerning the flow inside the production unit.

• Give more details about the latest cGMP requirement for equipment in both up and downstream.

• Give information about the HVAC system, air filtration and distribution.

• Represent the principles of writing a good SOP with some examples.

• Deliver basic information about the system of Qualification and Validation in Biopharmaceutical industries.

course objectives

www.ibd.utm.myINSTITUTE OF BIOPRODUCT DEVELOPMENT, UNIVERSITI TEKNOLOGI MALAYSIAenquiries

Jalan Sultan Yahya Petra, 54100 Kuala Lumpurtel : +603.2615 4406 Attn : Yatie email : nikyati@ibd.utm.my

81310 UTM Johor Bahru, Johortel : +607.553 1559 Attn : Asmafarhana email : asmafarhana@ibd.utm.my

course content

CGMP FACILITY FOR THEBIOPHARMACEUTICAL INDUSTRIES

i. Introduction – Biopharmaceutical business

ii. cGMP Basic Requirements

iii. cGMP Facilities

iv. cGMP for Biotechnology Production Area (From lab to store)

v. HVAC System for Clean Room (Design and Practice)

vi. cGMP for Biotechnology Production Area (From master cell bank to finished product store)

vii. cGMP for the Manufacturing Process

viii. cGMP and cGLP requirements

ix. Validation

Institute ofBioproduct Development

course tutorPROF. DR. RER. NAT. HESHAM A. EL ENSHASY | Prof. Dr. rer. Nat. Hesham A. El Ensashy is currently a Professor at IBD. He holds a PhD. in Industrial Biotechnology from TU Braunschweig, Germany and helds various postdoctoral positions at Ohio State Univ. and Germany Research Centre for Biotechnology (GBF), which now has changed its name to Helmholts Centre for Infec-tion Research. He established different research and industrial platforms for the production of biopharmaceutically important compounds using microbial and non-microbial cells. He also organized different training courses on operation and maintenance of biotechnology equipment both for upstream and downstream applications. Dr. El Enshasy is also working as consultant for biobusiness, technology transfer and biotech. facility design/auditing for many biopharmaceuti-cal companies in Egypt, Belgium, Greece, USA, China and Malaysia.

Fee is inclusive of lunch, refreshments and course materials.

Accommodation is not included.

Normal FeeRM 2,000

Student FeeRM 1,500

course fee

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Account name Bendahari UTM Bank CIMB Bank Berhad Account No 8006053536

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Cancellation & Substitutions

A) The organiser has the right to make any amendments that they deem to be in the best interest of the course and to cancel the course if insufficient registrations are received a week before course commencements date.

B) CERTIFICATE OF ATTENDANCE will be awarded at the end of the course.

A full refund will be promptly made for all written cancellations 2 weeks before the course. 50% refund will be made for written cancellations received 7 days before the course. A substitute may be made at any time.Note

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M5 : A 2 Day Course on CGMP Facility for the Biopharmaceutical Industries

6 - 7 MAY2019

7 - 8 OCT2019

venue:Jasmine Room, N22 IBD UTM Johor