Events

Process Validation Training

UpcomingProcess Validation Training – Sydney

Sydney Process Validation Training This one-day Process Validation training course is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the US FDA in 2011 and the EU and PIC/S Annex 15 in Qualification and Validation in October 2015. The aim of the course is to (more…)

  • Process Validation (SYD-20-05-20)
    20/05/2020
    9:00 am - 4:00 pm

Process Validation Training

UpcomingStatistics for Process Validation Training – Sydney

Sydney Statistics for Process Validation Training Statistics may not be for everyone but they are a fundamental part of GMP and all stages of process validation. We have developed an interactive course that will keep you engaged throughout the day as you develop a practical understanding through workshops and discussion of statistics in process validation (more…)

  • Stats for Process Validation (SYD-21-05-20)
    21/05/2020
    9:00 am - 4:00 pm

Quality Risk Management Training (ICH Q9)

UpcomingQuality Risk Management Training (ICH Q9) – Melbourne

Melbourne Quality Risk Management Training (ICH Q9) This Quality Risk Management (QRM) course is focused on how the QRM regulations apply to everyday pharmaceutical and biotech manufacturing processes and to accurately assess the risk to product quality and patient safety. As discussed at the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals (more…)

  • QRM ICHQ9 (MEL-02-06-20)
    02/06/2020
    9:00 am - 4:00 pm

Quality Risk Management Training (ICH Q9)

UpcomingQuality Risk Management Training (ICH Q9) – Sydney

Sydney Quality Risk Management Training (ICH Q9) This Quality Risk Management (QRM) course is focused on how the QRM regulations apply to everyday pharmaceutical and biotech manufacturing processes and to accurately assess the risk to product quality and patient safety. As discussed at the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals (more…)

  • QRM ICHQ9 (SYD-04-06-20)
    04/06/2020
    9:00 am - 4:00 pm

GAMP & Computerised Systems Validation Training

UpcomingGAMP & Computerised Systems Validation Training – Melbourne

Melbourne GAMP & Computerised Systems Validation Training This training course on how to validate computerised systems covers the essential principles on how to use a risk-based approach in Computer Systems Validation (CSV). The course provides a broad overview of GMP requirements for computerised systems and is designed for professionals seeking training on a practical and (more…)

  • GAMP (MEL-11-06-20)
    11/06/2020
    9:00 am - 4:00 pm

Self Inspection (internal audit) Training

UpcomingAuditor Training – Auckland

Auckland Auditor Training This Audit Training Course is designed to provide participants with detailed knowledge of self-inspection or external auditing best practices. This course will help you to understand how and why you need to monitor your GMP systems and how to identify, record and address necessary corrective actions and continuous improvement items as part (more…)

  • Self Inspection (AKL-17-06-20)
    17/06/2020
    9:00 am - 4:00 pm

CAPA

UpcomingCAPA Training – Auckland

Auckland CAPA Training This CAPA Training Course is designed to provide you with an overview of a typical Corrective Action and Preventive Action (CAPA) program to handle outputs as part of a Pharmaceutical Quality System (PQS). This course will help you to understand how to run an effective CAPA process and use it for continuous (more…)

  • CAPA Training (AKL-18-06-20)
    18/06/2020
    9:00 am - 4:00 pm

data-integrity-blog

UpcomingData Integrity Training – Melbourne

Melbourne Data Integrity Training Course The requirements for Data integrity are not new. It is implicit and always has been a foundation of Good Manufacturing Practice. The subject, however, has an increased profile as hybrid (paper and electronic) and electronic systems become more prevalent in modern manufacturing. Globally regulators are recruiting and training their inspectors (more…)

  • Data Integrity Training (MEL-30-06-20)
    30/06/2020
    9:00 am - 4:00 pm

data-integrity-blog

UpcomingData Integrity Training – Sydney

Sydney Data Integrity Training Course The requirements for Data integrity are not new. It is implicit and always has been a foundation of Good Manufacturing Practice. The subject, however, has an increased profile as hybrid (paper and electronic) and electronic systems become more prevalent in modern manufacturing. Globally regulators are recruiting and training their inspectors (more…)

  • Data Integrity Training (MEL-02-07-20)
    02/07/2020
    9:00 am - 4:00 pm