LOADING CLOSE

Events

Annex 1

Perth Annex 1 Training


  • Annex 1 revision (PER-21-02-18)
    21/02/2018
    9:00 am - 4:00 pm

The European Medicines Agency (EMA) has published the public draft of the long-awaited revision to Annex 1 of their GMPs, for the Manufacture Sterile Medicinal Products. This training course will dive deeper into the revisions and highlight changes that need to be considered for sterile manufacturers with markets subject to EMA or PIC/S. You may (more…)

Pharmaceutical Conference

Brisbane Industry Update Dinner


  • Industry Update Dinner (BRI-27-02-18)
    27/02/2018
    6:00 pm - 9:00 pm

Come along to PharmOut’s Industry Update Dinner and catch up with your peers, hear about current industry news from the FDA and MHRA and insights from a very busy 2017. Speakers and topics: How mature are our validation programmes? It’s been nearly 7 years since the FDA introduced their 3 stage approach to validation, and 2 years (more…)

Annex 1

Brisbane Annex 1 Training


  • Brisbane Annex 1 Training
    28/02/2018
    9:00 am - 4:00 pm

The European Medicines Agency (EMA) has published the public draft of the long-awaited revision to Annex 1 of their GMPs, for the Manufacture Sterile Medicinal Products. This training course will dive deeper into the revisions and highlight changes that need to be considered for sterile manufacturers with markets subject to EMA or PIC/S. You may (more…)

Annex 1

Sydney Annex 1 Training


  • Annex 1 revision (SYD-01-03-18)
    01/03/2018
    9:00 am - 4:00 pm

The European Medicines Agency (EMA) has published the public draft of the long-awaited revision to Annex 1 of their GMPs, for the Manufacture Sterile Medicinal Products. This training course will dive deeper into the revisions and highlight changes that need to be considered for sterile manufacturers with markets subject to EMA or PIC/S. You may (more…)

Sydney GMP SOP Technical Writing Training


  • Technical Writing (SYD-06-03-18)
    06/03/2018
    9:00 am - 4:00 pm

Sydney GMP SOP Technical Writing Training Well written technical SOP’s help employees understand information the first time they read or hear it. Who doesn’t want to improve compliance, shorten induction time and reduce deviations caused by confusing procedures? If you are asked to write SOPs as part of your job role, would you like some (more…)

Self Inspection (internal audit) Training

Melbourne Self Inspection (internal audit) Training


  • Self Inspection (MEL-13-03-18)
    13/03/2018
    9:00 am - 4:00 pm

Melbourne Self Inspection (internal audit) Training This Internal Audit Training Course is designed to provide participants with detailed knowledge of self inspection or internal 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 (more…)

Self Inspection (internal audit) Training

Adelaide Self Inspection (internal audit) Training


  • Self Inspection (ADE-14-03-18)
    14/03/2018
    9:00 am - 4:00 pm

Adelaide Self Inspection (internal audit) Training This Internal Audit Training Course is designed to provide participants with detailed knowledge of self inspection or internal 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 (more…)

GAMP & Computerised Systems Validation Training

Adelaide GAMP & Computerised Systems Validation Training


  • GAMP (ADE-15-03-18)
    15/03/2018
    9:00 am - 4:00 pm

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…)

PIC/S GMP Training Course PE 009-13

Melbourne PIC/S PE009 GMP


  • PIC/S GMPs (MEL-16-03-18)
    16/03/2018
    9:00 am - 4:00 pm

Melbourne PIC/S PE009 GMP The PIC/S Code of GMP for the manufacture of medicinal products PE 009 version 13 which came into effect in January 2017 we re offering a 1 day training course covering the essential “what you need to know”. New PIC/S GMP version 13 This full day course will be facilitated by (more…)

Sydney Design, Commissioning, Qualification and Startup of Cleanrooms


  • Cleanrooms (SYD-21-03-18)
    21/03/2018
    9:00 am - 4:00 pm

Sydney Design, commissioning, qualification and startup of cleanrooms 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, installation, commissioning, and start-up of a cleanroom. The course also addresses the essential requirements of critical utilities that serve the cleanrooms (more…)