ISPE Malaysia Affiliate

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ISPE Malaysia Affiliate

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Since then, ISPE Malaysia membership has expanded not only among the pharmaceutical industry but also other professionals and areas of interest as well.

The Malaysia Affiliate benefits our membership with an active events calendar, pharmaceutical engineering and GMP compliance education and training and promotes networking between professionals within the pharmaceutical and medical device industry. ISPE Malaysia Affiliate was established in January 2012 by a group of industry leaders who believed the Malaysian pharmaceutical industry needed an organization and platform that would deal with practical applications of scientific and technical knowledge for our industry professionals. Our members consist of professionals in the pharmaceutical and healthcare industry, suppliers, regulators, government agencies, academia and students. This diverse mix represents the healthcare ecosystem in Malaysia and provides a balanced view of the knowledge and skills needed to drive Malaysia towards being a key player in the development and manufacture of safe and effective medicines. ISPE Malaysia Affiliate also aims to serve as a platform to bring our members closer, sharing good practices, technical updates and knowledge with each other locally as well as through our international network of 18,000 strong members in more than 90 countries around the world. Every year, we have an exciting calendar of education training events, networking opportunities and virtual conferences planned that will provide valuable information in key strategic areas for our members. Contact details:
Office address: Level 41, Vista Tower, The Intermark, 348, Jalan Tun Razak, 50400 Kuala Lumpur. Tel: +(60)3-2703 8350
Email: [email protected]

Website: https://www.ispemalaysia.org/
LinkedIn: https://www.linkedin.com/company/ispe-malaysia-affiliate

01/10/2026

✨ 𝙇𝙀𝘼𝘿𝙁𝙊𝙍𝙂𝙀 2026: 𝙁𝙊𝙍𝙂𝙄𝙉𝙂 𝙁𝙐𝙏𝙐𝙍𝙀 𝙇𝙀𝘼𝘿𝙀𝙍𝙎 ✨

The wait is over!!! You’ve heard about LEADFORGE 2026, now, here are the details. 👀

Get ready for 2 𝙙𝙖𝙮𝙨 of learning, challenges, connection and leadership growth as we bring you a camp designed to inspire and equip the future leaders of tomorrow. 🌱

📅 12–13 November 2026 (Thursday–Friday)
📍 The Kabin, Jeram, Selangor
💰 RM30 per person
🚌 Bus provided | Gathering point: SEGi University

Expect engaging activities, team challenges, insightful sessions and plenty of opportunities to connect with fellow future leaders. 🤝

𝑳𝑬𝑨𝑹𝑵. 𝑳𝑬𝑨𝑫. 𝑪𝑶𝑵𝑵𝑬𝑪𝑻. 𝑴𝑨𝑲𝑬 𝑨𝑵 𝑰𝑴𝑷𝑨𝑪𝑻.

🎟️ Registration is now OPEN! Scan the QR code to register NOW!
https://docs.google.com/forms/d/e/1FAIpQLSdooJn1D232yOZjH4YvD8oe_gHUyOMF_0xCbIktlF11mNMWRQ/viewform

For enquiries:
📞 Joele: +60 19-737 0705
📞 Adawiah: +60 17-989 5422
📞 Nurul: +60 11-6075 8387

20/09/2026

Contamination control doesn’t stop at the cleanroom door.

It starts with how we design.

It continues with how we monitor.

And it becomes stronger when the data tells us what we need to know.

ISPE Malaysia, in collaboration with Charles River Laboratories, invites you to the 2026 ISPE Malaysia Technical Seminar, where we connect the dots between cleanroom design, Environmental Monitoring, microbial identification and Contamination Control Strategy through practical insights and real-world case studies.

📅 Monday, 2 November 2026
⏱️ 8:30 AM — 3:30 PM
📍 Four Points by Sheraton Puchong

Contamination Control in Pharma Manufacturing: Designing for Quality and Compliance

One day. Practical conversations. Different perspectives. One shared objective: better contamination control.

Come learn. Ask questions. Exchange experiences. Connect with the community.

Registration is now open. See you there!

https://forms.gle/4QVs1MnBPw5C6Zu28

16/09/2026

Malaysia is built on diversity.

Different cultures. Different background. Different perspectives. Yet, we move forward as one nation with a shared hope for a better tomorrow.

The same spirit can be found within our pharmaceutical communities, where people from different disciplines, organisations and generations come together with a common purpose, to learn, collaborate and contribute towards better healthcare and a better future.

This Malaysia Day, let us celebrate not only how far we have come, but also the connections, partnerships and shared purpose that continue to move us forward.

Many backgrounds. One Malaysia. One shared purpose.

Selamat Hari Malaysia from all of us at ISPE Malaysia Affiliate.

15/09/2026

We’ve reached 3,000!

But this milestone isn’t really about the number.

It’s about the people behind it. Our members, volunteers, speakers, industry partners, students, young professionals and friends who continue to connect, contribute and grow with ISPE Malaysia.

To all 3,000 of you, thank you for being part of our community.

We learn. We connect. We share. We grow. Together.

11/09/2026

Two years on, what have we learned from Annex 1 implementation?

On 8 September, at the 2026 ISPE Malaysia Conference & Exhibition, our panel discussion, “Annex 1 Implementation: Thoughts After More Than 2 Years’ Experience”, brought together regulatory, manufacturing, engineering and technical perspectives for an engaging exchange on the realities of implementation.

Moderated by Zarina Noordin, President, ISPE Malaysia Affiliate, with panellists:

1. Ms. Fazillahnor Ab Rahim, NPRA

2. Chai Richard, STERIS

3. ANKUR VERMA, Hyde Engineering + Consulting

4. Mohd Latiffi Abdul Aziz, Pharmaniaga LifeScience Sdn. Bhd.

The discussion reflected on lessons learned, practical challenges and how contamination control continues to evolve more than two years into Annex 1 implementation.

ISPE Malaysia Affiliate extends our sincere appreciation to our moderator and panellists for generously sharing their experience, perspectives and practical insights with the industry.

Different perspectives, shared learning and a common commitment to advancing contamination control and patient safety.

11/09/2026

2026 ISPE MYSCB & Emerging Leader 3-Minute Pitch Competition-Event Highlights

The 2026 ISPE MYSCB & Emerging Leader 3-Minute Pitch Competition was successfully held on 6 September 2026 at Putrajaya Marriott Hotel. The event brought together students and emerging leaders to present innovative ideas and proposed solutions relevant to the pharmaceutical and life sciences sectors.

The event commenced with an inspiring opening address by Puan Zarina Nordin, President of the ISPE Malaysia Affiliate. The competition was organised under the guidance of Assoc Prof Dr Najwa Mohamad, Advisor to the 3-Minute Pitch Competition and ISPE MYSCB.

Through concise three-minute presentations, participants demonstrated their ability to communicate complex concepts with clarity, confidence and impact while showcasing creativity, technical understanding, feasibility and industry relevance.

The competition provided a valuable platform to encourage innovation, strengthen communication and presentation skills, and support participants’ professional development at different stages of their academic and professional journeys.

We extend our sincere appreciation to our distinguished panel of judges—Datin Paduka Dr Teo Soo Hwang, Mrs Noorhayati M. Nasir, Mrs Chan Li Jin and Mr Leonard Lai Yoong Hong—for their valuable time, insights and contributions throughout the competition.

A special thank you also goes to all participants, committee members, volunteers and supporting parties whose dedication and teamwork contributed to the successful ex*****on of the event.

PharmaceuticalInnovation FutureOfPharma ISPE2026

11/09/2026

Is your manufacturing site ready to bridge the gap between AI innovation and GxP compliance?

Artificial Intelligence is rapidly shifting from experimental pilot projects to mission-critical infrastructure on the pharmaceutical shop floor. However, in highly regulated environments, deploying AI isn’t just about technical feasibility, it requires robust validation frameworks, explainability, and adherence to strict data integrity standards without compromising patient safety or product quality.

Join ISPE Malaysia Affiliate for an exclusive, complimentary session in our 2026 Webinar Series (Theme: Development): Implementation of AI to Support Manufacturing Operations.

Session Details:
📅 Date: Monday, 28 September 2026
⏰ Time: 2:30 PM – 3:30 PM (MYT)
💻 Platform: Virtual / Online Webinar
🎟️ Admission: Complimentary (Pre-registration required)
⏳ Registration Closes: Sunday, 27 September 2026

Equip your technical team with practical, audit-ready strategies for AI implementation. Secure your complimentary seat or scan the QR code in the flyer to register.

👉 Register for Free: https://ispemalaysia.org/event/2026-ispe-my-webinar-implementation-of-ai-to-support-manufacturing-operations/

11/09/2026

A sincere thank you to Ms Fazillahnor Ab Rahim of National Pharmaceutical Regulatory Agency (NPRA) for joining us at the 2026 ISPE Malaysia Conference & Exhibition.

On 8 September, Ms Fazillahnor Ab Rahim, Senior Principal Assistant Director, Good Manufacturing Practice (GMP) Section, NPRA, shared her perspectives on:

“Considerations for CCS Implementation in Non-Sterile Facilities”

Contamination Control Strategy, or CCS, is often closely associated with sterile manufacturing. However, the principles of contamination control, risk assessment and a structured approach to managing contamination risks are equally important considerations in non-sterile environments.

Ms Fazillahnor’s presentation brought valuable regulatory perspectives to this important topic, providing the industry with a broader understanding of how CCS principles can be considered and applied within non-sterile manufacturing environments.

At ISPE Malaysia, we greatly value opportunities that bring regulators and industry professionals together to exchange knowledge, perspectives and experiences, strengthening our collective understanding and supporting continuous improvement across the pharmaceutical industry.

Our sincere appreciation to Ms Fazillahnor for her time, knowledge and valuable contribution to the conference. It was a privilege to have you with us.

08/09/2026

🔥 Wrapping up Day 2! Key takeaways from the afternoon at Track 2 :

🔹 Strategies to minimize downtime during expansion of the PW system
🔹Sterile Filtration in the Annex 1 Era: Interpreting PDA TR 26 (Revised 2025)
🔹Operational Excellence Begins With Effective Cleaning & Disinfection

🙏 Thank you to our speakers & delegates for an incredible day of learning & collaboration!

08/09/2026

🔥 Wrapping up Day 2! Key takeaways from the afternoon at Track 1 :

🔹 Recombinant Technologies: Enabling Compliance, Sustainability, and Innovation
🔹Containment and Barrier Isolator Application in High Potent Production

🙏 Thank you to our speakers & delegates for an incredible day of learning & collaboration!

Address

Kuala Lumpur
50450

Telephone

+60327038350

Website

http://www.ispemalaysia.org/

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Yayasan AMAL Malaysia - Wilayah
8-A, Lorong Chow Kit, 4, Jalan Raja Laut

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