Events

US FDA release a preliminary report on the New England Compounding Centre

UpcomingSOP Technical Writing Training – Virtual

Virtual SOP Technical Writing Training Well written technical SOPs 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 straightforward (more…)

  • Technical Writing (VIR-07-07-22 AEST)
    07/07/2022
    9:00 am - 4:00 pm

CAPA

UpcomingCAPA Training – Virtual

Virtual 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 (VIR-12-07-22 AEST)
    12/07/2022
    9:00 am - 4:00 pm

Good Distribution Practice

UpcomingGood Distribution Practice – Virtual

Virtual Good Distribution Practice This Good Distribution Practice (GDP) Training Course is designed to cover the latest GMP requirements in the distribution and/or warehousing of medicinal products. It covers the current GMP guidelines and recent updates. The course will help you understand the importance of correctly managing an integrated supply chain. Distribution networks are becoming (more…)

  • GDP (VIR-19-07-22 AEST)
    19/07/2022
    9:00 am - 4:00 pm

hot-topics-news-in-pharmaceutical-manufacturing-industry

UpcomingIndustry Update Dinner

Fed up with Zoom meetings, ready for some face to face interaction with your peers? Come along to the PharmOut Industry Update Dinner and catch up on the latest topics and news! Entrée A Post Covid World – Innovations through the eyes of Jason Clarke – clearly there has been a significant digitalisation, Intel have (more…)

  • Industry Update Dinner (MEL-20-07-22)
    20/07/2022
    5:30 pm - 8:30 pm

Quality Risk Management Training (ICH Q9)

UpcomingQuality Risk Management Training (ICH Q9) – Virtual

Virtual 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 (VIR-04-08-22 AEST)
    04/08/2022
    9:00 am - 4:00 pm

iso 13485

UpcomingQuality Management Systems – ISO13485 Training – Virtual

Virtual Quality Management Systems – ISO 13485 training course This one day ISO 13485 training course covers the requirements of ISO 13485 and its implications within a medical device manufacturing company. PharmOut’s consultants regularly design and write Quality Management Systems for companies, from the smallest to the large blue-chip companies. They have many practical suggestions (more…)

  • QMS - ISO13485 (VIR-09-08-22 AEST)
    09/08/2022
    9:00 am - 4:00 pm

Process Validation Training

UpcomingProcess Validation Training – Virtual

Process Validation Training – Virtual 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 Qualification and Validation. The aim of the course is to provide practical insights (more…)

  • Process Validation (VIR-11-08-22 AEST)
    11/08/2022
    9:00 am - 4:00 pm

Cleaning Validation Training

UpcomingCleaning Validation Training – Virtual

Cleaning Validation Training – Virtual This Cleaning Validation (CV) Training Course is to provide participants with an overview of a typical cleaning validation program. The course will help you understand the three phases of a lifecycle CV program (like the three stages of Process Validation) and will step through each part. We regularly offer Cleaning (more…)

  • Cleaning Validation (VIR-24-08-22 AEST)
    24/08/2022
    9:00 am - 4:00 pm

data-integrity-blog

UpcomingData Integrity Training – Virtual

Virtual 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 (VIR-30-08-22 AEST)
    30/08/2022
    9:00 am - 4:00 pm