Location: Bandar Baru BangiMicrobial contamination is one of the major challenges faced by manufacturing companies within the GMP regulated industries. Microbial contamination will lead to production downtime, time spent on investigation, product recall and risk to patient safety. Numerous product recalls due to microbial contamination in the past lead to increased scrutiny during regulatory inspections.
Technical Service Manager, Richard Chai is leading a day long ISPE Malaysia seminar that will enable the participants to gain a valuable insight into the various factors that can lead to microbial contamination in process equipment, the remediation procedures, as well as the various measures which can be implemented to mitigate the risk of microbial contamination.
The following topics will be discussed in detail for this presentation:
Regulatory perspective on microbial contamination, including regulations and warning letters.
Potential sources of microbial contamination, and various factors that can lead to microbial contamination such as rouge and biofilm. Each of these factors will be discussed in detail, including the causes and the remediation.
Designing a robust cleaning program that can effectively remove product residue and also minimize the risk of microbial contamination. This will include the selection of cleaning agents, understanding the cleaning mechanisms and critical cleaning parameters.
At the end of the seminar, the participants will have a better understanding of the various factors that can lead to microbial contamination in process equipment, the remediation procedures, and also the preventive measures which can be implemented to mitigate the risk of microbial contamination.
Who should attend: Personnel from QC, QA, QM, Validation, Research & Development, Manufacturing, Regulators, Academia and Students.
Time: 8.30am - 5.00pm (lunch and breaks provided)
Ordinary Member: RM 50
Non Member: RM 150
Government Agencies & Academia Member: Free
YP & Student Member: Free
Click Here to Register