14 April 2020
Event dates: 5/6 May 2020
Quality Risk Management (QRM) was introduced to the GMPs in 2009 and should now be an integrated part of your daily pharmaceutical manufacturing operations…but is it?
This SeerPharma training course can help you by providing you with sufficient knowledge and skills to effectively participate in process risk assessments. You will gain a general understanding of manufacturing processes and how they are controlled, as well as an understanding of the Risk Assessment Process to ensure you have a basis from which to conduct a structured risk evaluation.
You will learn about:
Case studies drawn from the following real life scenarios will be workshopped to provide you with both industry examples and hands-on practice in the use of three of the more complex process risk assessment tools (defined in ICH Q9) – PHA, FMEA, HACCP:
This course is designed for both personnel new to process risk assessment as well as more experienced QRM practitioners. You will benefit from this course if you have a simple interest in or have any level of responsibility for risk assessments of manufacturing processes.
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will delivered as 2 x 3.5 hour sessions over 2 days. Each 3.5 hour session will include a break.
PDF Certificates will be provided to participants electronically.
Each participant will attend both half-day sessions:
|Day 1||5th May 2020||8:30am join for 9:00am-12:30pm|
|Day 2||6th May 2020||8:45am join for 9:00am-12:30pm|
Times are based on Melbourne, Sydney and Brisbane; Australian Easter Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00
Participants to join at 8:30am in advance of a 9:00am start on day 1, giving time to address any technical issues. There will be a break during each session and we anticipate each session to finish at 12:30pm.
Find out more and register here.