This course will help by stepping you through the key requirements as per the PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part I. Using case studies and examples drawn from industry and consulting experience, you will learn the requirements and how they are applied to your regulated operations and related controls; with a focus on ensuring product quality and the avoidance of cross-contamination/mix-ups to prevent product adulteration and misbranding.
- An overview of the global regulatory environment
- GMP Basics: Personnel and Training, Equipment and Facilities, Production and Packaging Controls, Validation, Quality Control, Out-of-Specification, Stability Programs
- Good documentation and record keeping practices
- Quality Management Basics: A Quality-System approach to GMP, Quality Risk Management, Managing Changes and Deviations, Product Quality Reviews
- Workshops exploring common GMP problems and solutions
This course has been designed to provide personnel new to the pharmaceutical industry with a good understanding of PIC/S GMP and Pharmaceutical Quality System requirements. It also applies to experienced GMP staff looking for a refresher, or existing companies that require a new GMP licence or GMP certificate from the regulatory bodies, including 3rd party logistics (3PL) providers that repack/reprocess medicines.
Format and Course Length
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 be delivered as 2 full day sessions with breaks.
PDF Certificates will be provided to participants electronically.
Each participant will attend both full-day sessions:
|Day 1||17 August 2020||8:45am join for 9:00am-5:00pm|
|Day 2||18 August 2020||8:45am join for 9:00am-5:00pm|
Times are based on Singapore time (SGT): UTC +8:00
Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.
- SGD $1,391 per participant
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Contact us for clarification or to discuss your interest in a private delivery of this course on-site or in a virtual-classroom.