The ability to monitor systems continuously is essential for businesses to remain compliant with industry regulations and to operate efficiently. However, it is not enough to simply have a continuous monitoring system in place. It is equally important to ensure that the system is audit-proof, meaning it can withstand the scrutiny of regulatory inspections and audits.

Dpstar Group and Vaisala are collaborating to organize this seminar on how to Audit-proof Your GxP Environmental Monitoring System. The seminar will cover best practices for monitoring and recording critical environmental parameters, such as temperature, humidity, and differential pressure, to maintain compliance with regulatory requirements. The seminar will also cover key aspects of data management, such as data integrity, accessibility, and security.

This seminar is highly relevant for industries such as pharmaceuticals, healthcare, and food and beverage, where strict adherence to regulatory standards is of utmost importance. The seminar will provide participants with practical knowledge and tools to enhance the accuracy and reliability of their monitoring systems and to be better prepared for regulatory audits. By attending this seminar, you will gain valuable knowledge and skills that can help you stay competitive and succeed in today’s fast-paced and ever-evolving industry.

Seminar Program

8.30am-9.00am Registration & Networking session
9.00am -9.10am Welcoming Address by ISPE Malaysia
9.10am – 10.30am CMS Seminar by Mr. Paul Daniel
10.30am – 11.00am Coffee Break
11.00am – 12.45pm CMS Seminar by Mr. Paul Daniel (Cont’d)
12.45pm – 1.45pm Lunch Break
1.45pm -3.30pm CMS Seminar by Mr. Paul Daniel (Cont’d)
3.30pm-3.45pm Tea Break
4.00pm-4.30pm Q&A Session with Mr. Paul Daniel
4.30pm – 5.00pm Photo Session with Mr. Paul Daniel and participants
5.00pm End of Seminar

Seminar Program

Learning Outcomes

Validation documentation problems
Issues with the documentation required to validate a process or system can lead to non-compliance with regulatory requirements.

Outdated or non-existent training records
Outdated or non-existent training records can result in compliance problems and potential safety risks.

No SOPs for environmental monitoring applications
The absence of SOPs for environmental monitoring can result in inconsistent practices and regulatory non-compliance.

Validation documentation problems
Issues with the documentation required to validate a process or system can lead to non-compliance with regulatory requirements.

Outdated or non-existent training records
Outdated or non-existent training records can result in compliance problems and potential safety risks.

No SOPs for environmental monitoring applications
The absence of SOPs for environmental monitoring can result in inconsistent practices and regulatory non-compliance.

Past due calibration or missing calibration records
Past due or missing calibration records can lead to inaccurate measurements and regulatory non-compliance.

Change Control procedures not followed
Failure to follow change control procedures can lead to product or process deviations, which can result in regulatory non-compliance and potential safety risks.

Security issues – I.E. personnel access to software
Security issues, such as unauthorized access or data breaches, can have serious consequences, including the compromise of critical data and regulatory non-compliance.

Past due calibration or missing calibration records
Past due or missing calibration records can lead to inaccurate measurements and regulatory non-compliance.

Change Control procedures not followed
Failure to follow change control procedures can lead to product or process deviations, which can result in regulatory non-compliance and potential safety risks.

Security issues – I.E. personnel access to software
Security issues, such as unauthorized access or data breaches, can have serious consequences, including the compromise of critical data and regulatory non-compliance.

Speaker

The seminar is hosted by Paul Daniel who has more than 20 years of experience in helping manufacturers apply good manufacturing practices in a wide range of qualification projects. A senior GxP Regulatory Expert at Vaisala, he specializes in mapping, monitoring, and computerized systems, in which he oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system.

Speaker

The seminar is hosted by Paul Daniel who has more than 20 years of experience in helping manufacturers apply good manufacturing practices in a wide range of qualification projects. A senior GxP Regulatory Expert at Vaisala, he specializes in mapping, monitoring, and computerized systems, in which he oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system.