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ABOUT

US

The ISPE Malaysia Affiliate is here for all professionals in the pharmaceuticals, healthcare, medical devices & related industries.

Copyright © 2019 ISPE Malaysia | 

International Society For Pharmaceutical Engineering (M)

CONTACT

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Level 41, Vista Tower, The Intermark

348, Jalan Tun Razak

50400 Kuala Lumpur

MALAYSIA

TRAINING & EVENTS 2018

Analysis of Findings from GMP Inspections of Pharmaceutical Manufacturers & Introduction to ‘Guidance Document of Pre-Approval GMP Inspection’

DATE: 17 October 2018 (Wednesday)

TIME: 9:30 AM - 4:00 PM

VENUE: THE ROYALE CHULAN DAMANSARA HOTEL, Petaling Jaya

Who should attend
Manufacturers and relevant personnel in various departments in pharmaceutical industry.
 

Objectives
• To share with the industry the analysis of findings from GMP inspections of pharmaceutical manufacturers.
• To enhance the understanding of GMP requirements in pharmaceutical manufacturers
• To introduce a new document by NPRA – ‘Guidance document of Pre-approval GMP Inspection’
• A platform for sharing GMP inspection related issues between NPRA and industry

Deadline for registration: 5.00pm, 10 October 2018
 

An Audit Approach to Address Microbial Contamination in Process Equipment

DATE: 24 July 2018 (Tuesday)

TIME: 8:30 AM – 5:00 PM

VENUE: Hotel Bangi-Putrajaya, Bandar Baru Bangi, SELANGOR

Who should attend
Personnel from QC, QA, QM, Validation, Research and Development, Manufacturing, Regulators, Academia and Students

Contamination & Cross-contamination Control in Multi-Product Facilities

DATE: 12 & 13 July 2018 (Thursday & Friday)

TIME: 8:30 AM – 5:00 PM

VENUE: Hotel Bangi-Putrajaya, Bandar Baru Bangi, SELANGOR

Objectives
The objective of this comprehensive 2-day education and training course is to provide attendees
with the essential information and tools to design and operate a multi-product factory safely. This
will help ensure that the participants to pay optimal attention to critical issues during design,
qualification and routine operation of a multi-product factory.
You will learn about:

  • The GMP requirements for cross-contamination control in current and future versions of PIC/S GMP Chapters 3 & 5.

  • Understanding the principles of HBEL (Health based exposure limit) applied to cross-contamination control.

  • Practical ‘Risk Assessment’ TOOLs. Understand ‘Fishbone’ (cause and effect) and ‘FMEA’ techniques.

  • Learn about the ISPE guidance available – RiskMaPP™ Baseline Guide, and The ISPE Good Practice Guide: Assessing the (particulate) Containment Performance of Pharmaceutical Equipment.

  • Mitigation measures – Factory layout, Environmental control techniques, and process equipment designs.

  • The relationship with Occupational Health and Safety.

  • Measurement of airborne contamination in the workplace.

  • Tools for classifying and grouping of product by risk category
     

Who should attend
Personnel from Manufacturing, QA/QC, Validation. Also applicable to design & construction professionals, specialist suppliers, and personnel involved in the operation of pharmaceutical factories (multi-product) where cross-contamination is a risk

Closing Date: 10 July 2018

ISPE Malaysia 7th Annual General Meeting (AGM) 2018 & Hari Raya Celebration

DATE: 4 July 2018 (Wednesday)

TIME:

VENUE: Hotel Bangi-Putrajaya, Bandar Baru Bangi, SELANGOR

 

TALK ON: ASEAN Experiences in Biopharmaceutical Development

No registration fee

 

ISPE Members & Non Members are welcome!

Celebrate with us on this joyous occasion!

Good Distribution Practice (GDP)

DATE: 7 May 2018 (Monday)

TIME: 9.00 am – 5.00 pm

VENUE: THE ROYALE CHULAN DAMANSARA, Petaling Jaya

Objectives
• To highlight changes in the latest Guideline on GDP (3rd Edition, 2018)
• To share NPRA’s experience on GDP inspections
• To keep abreast of knowledge relevant to GDP

Who should attend
Manufacturers, importers, wholesalers and relevant parties involved in the storage / distribution of registered products and / or notified cosmetics

For Registration Fees and other details, download the flyer below.
 

Latihan Untuk Industri: KEPERLUAN PEMERIKSAAN APB PENGILANG VETERINAR

TARIKH: 24 & 25 April 2018 (Selasa & Rabu)
MASA: 9:00 pagi – 5:00 petang

LOKASI: Royale Chulan Damansara, Petaling Jaya
 

PENYERTAAN DI BUKA KEPADA: Pengilang Veterinar di Malaysia
 

Briefing on: UPDATES ON FOREIGN GMP REGULATORY INSPECTION 2019

DATE: 13 March 2018

TIME: 8:30 AM - 12:00 PM

VENUE: Hotel Royale Chulan The Curve
 

SPEAKERS:
From the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia
 

OBJECTIVES:
1. To disseminate information about the latest regulatory requirements relating to foreign GMP
regulatory inspections.
2. To introduce a new work process by NPRA – GMP Desktop Audit Assessment (GDA) for foreign manufacturers.
 

Towards Operational Excellence – Get Things Done Better

DATE: 9 February 2018

TIME: 8:30 AM - 5:00 PM GMT+8

VENUE: Hotel Bangi-Putrajaya, Bandar Baru Bangi, SELANGOR

SPEAKERS: 

1.  Mr. Daryl Lee, Business Unit Manager, Operational Excellence at Neville-Clarke (M) Sdn Bhd
2. Ms. Chantal Wee, Head of Business Unit, People Development at Neville-Clarke (M) Sdn Bhd
 

Who should attend:

Personnel from Manufacturing, Logistics, Commercial division etc. and anybody interested in improvement of work processes and development of influencing skills

 

Closing Date: 6 February 2018

 

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