Events

data integrity training course

UpcomingAdelaide Data Integrity Training

Adelaide Data Integrity Training Course The requirements around Data integrity are not new. It is implicit, and always has been s 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 (more…)

  • Data Integrity Training (ADL-22-06-18)
    22/06/2018
    9:00 am - 4:00 pm

GMP Facility Design

UpcomingSydney GMP Facility Design

The purpose of this course is to provide participants with a detailed understanding about the practical application of the GMP Codes and guidelines to the design of a GMP facility. The course covers both sterile and non-sterile facilities and also addresses the essential requirements of critical utilities that serve the cleanrooms and the processes within (more…)

  • GMP Facility Design
    27/06/2018
    9:00 am - 4:00 pm

GAMP & Computerised Systems Validation Training

UpcomingAdelaide GAMP & Computerised Systems Validation Training

Adelaide GAMP & Computerised Systems Validation Training Course 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 (more…)

  • GAMP (ADE-29-06-18)
    29/06/2018
    9:00 am - 4:00 pm

data integrity training course

UpcomingSydney Data Integrity Training

Sydney Data Integrity Training Course The requirements around Data integrity are not new. It is implicit, and always has been s 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 (more…)

  • Data Integrity Training (SYD-04-07-18)
    04/07/2018
    9:00 am - 4:00 pm

Plan Do Check Act - CAPA

UpcomingMelbourne CAPA Training

Melbourne 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 (MEL-13-07-18)
    13/07/2018
    9:00 am - 4:00 pm
  • CAPA Training (MEL-20-11-18)
    20/11/2018
    9:00 am - 4:00 pm

GAMP & Computerised Systems Validation Training

UpcomingBrisbane GAMP & Computerised Systems Validation Training

Brisbane GAMP & Computerised Systems Validation Training Course 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 (more…)

  • GAMP (BRI-13-07-18)
    13/07/2018
    9:00 am - 4:00 pm

Process Validation Training

UpcomingBrisbane Process Validation Training

Brisbane 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 (BRI-17-07-18)
    17/07/2018
    9:00 am - 4:00 pm

PIC/S GMP Training Course PE 009-13

Sold OutAuckland PIC/S PE009 GMP

Auckland PIC/S PE009 GMP The PIC/S Code of GMP for the manufacture of medicinal products PE 009 version 13 is due to come into effect in 2017. Australia may or may not automatically adopt the changes-even if they don’t lets still discuss them! In this session, we will be covering the most significant changes since (more…)

  • PIC/S PE009 GMP (AKL-18-07-18)
    18/07/2018
    9:00 am - 4:00 pm

Quality Risk Management Training (ICH Q9)

UpcomingSydney Quality Risk Management Training (ICH Q9)

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…)

  • Quality Risk Management (SYD-24-07-18)
    24/07/2018
    9:00 am - 4:00 pm