TRAINING & EVENTS 2020
Webinar: Filter Integrity Test Troubleshooting - Beyond Rewet and Retest.
[FREE WEBINAR FOR ISPE MEMBERS !! ]
Speaker: Mr. Somasundaram G., Senior Technical Consultant, Merck KGaA. k
DATE: 21th Oct 2020
TIME: 14:00pm - 15: 30pm (Malaysia Time)
Who should attend : Personnel from QC, QA, QM, Validation, Research & Development, Manufacturing, Regulators, Academia & Students
REGISTRATION FEES
ISPE Members : FREE
Non-members : RM70 (For foreigners: USD18)
In this webinar, you will learn:
- Gain confidence in your integrity testing results
- Provide justification for retests
- Understand specific challenges and eliminate them to assure the integrity test can be performed correctly the first time
Webinar: BioPhorum Raw Materials Risk Assessments and how Emprove® Program can support
[FREE WEBINAR FOR ISPE MEMBERS !! ]
Speaker:Dr. Torsten Schaderdorf, Marketing Manager, Merck
DATE: 29th Sept 2020
TIME: 15:30pm - 16: 30pm (Malaysia Time)
Who should attend : Personnel from QC, QA, QM, Validation, Research & Development, Manufacturing, Regulators, Academia & Students
REGISTRATION FEES
ISPE Members : FREE
Non-members : RM50 (For foreigners: USD15)
In this webinar, you will learn:
- Overview of current regulations addressing Raw Material (RM) Risk Assessment
- Risk Criteria and Raw material scope as per BioPhorum guide
- How the Emprove Program can support RM Risk Assessment
In this session, you will be introduced to BioPhorum's (BPOG) focus on raw materials risk assessment and it's tool as a holistic approach through industry collaboration. Furthermore, a short overview on regulations addressing "raw material risk assessment" will be given. Finally, a link is given from BioPhorum’s publication to our Emprove Program showing how information within the Emprove Program can support drug manufacturer with their risk assessments.
Webinar: Controlling DI Risks With GMP Manufacturing Software
[FREE WEBINAR FOR ISPE MEMBERS !! ]
Speaker: David Margetts, CEO FactoryTalk Co. Ltd.
DATE: 13th AUGUST 2020
TIME: 11:00am - 12: 30pm
Who should attend : Personnel from QC, QA, QM, Validation, Research & Development, Manufacturing, Regulators, Academia & Students
REGISTRATION FEES
ISPE Members : FREE
Non-members : RM100
This webinar will demonstrate to participants how to identify and control common risks to manufacturing DI, by applying the latest risk-based thinking to typical GMP scenarios, and using modern (and considerably cheaper) software tools to control and automate quality work. This can often involve breaking the traditional ISA-95 "level's" based thinking in search of a more practical and pragmatic approach, focusing the right tools in the right place.
[POSTPONED] Data Integrity – Looking Beyond the Lab
[UPDATE]
THE EVENT IS POSTPONED DUE TO COVID-19 UNTIL FURTHER NOTICE
DATE: 31 March 2020 (Tuesday)
TIME: 8.30 am – 5.30 pm
VENUE: Royale Chulan Damansara Hotel, Mutiara Damansara
Speakers from NPRA and industrial Experts (FactoryTalk Co.Ltd.)
Who should attend
Personnel from QC, QA, QM, Validation, Research & Development, Manufacturing, Regulators, Academia & Students
Overview of Cleaning Validation and Elements of an Effective Bioburden Control Strategy
DATE: 25 February 2020 (Tuesday)
TIME: 8.30 am – 5.00 pm
VENUE: Bangi Resort Hotel, Bandar Baru Bangi
Speakers: Richard Chai & Neo Aik Ann from STERIS Corporation
Who should attend
Personnel from QC, QA, QM, Validation, Research & Development, Manufacturing, Regulators, Academia & Students
This seminar focuses on the important elements of contamination control strategies to minimize the contamination risk
POWDER HANDLING AND CONTAINMENT
DATE: 21 January 2020 (Tuesday)
TIME: 8.30 am – 5.00 pm
VENUE: Bangi Resort Hotel, Bandar Baru Bangi
Speakers: Frédéric Dietrich, Managing Director of Dietrich Engineering Consultants sa
Who should attend
Personnel from the pharmaceutical industry, and those involved in Manufacturing, Engineering and
QA/QC, Technical services. Regulators, Government Agency, Academia and Students.
Objectives:
• To highlight safety considerations when handling powders.
• To discuss challenges and issues relating to productivity and safety in pharmaceutical & chemical industries.