If you are responsible for any part of pharmaceutical product quality or GMP compliance, you must understand your legal and ethical obligations. To understand your obligations, you must understand the regulatory environment, intent and requirements of a Pharmaceutical Quality System, and current Good Manufacturing Practice as defined by PIC/S. To support GMP-regulated organisations, this course will help by stepping you through the various requirements of the current PIC/S Guide to GMP 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 manufacturing environment(s), with a focus on ensuring product quality and the prevention of adulteration and misbranding.
- Overview of the Global Regulatory Environment
- Drug product lifecycle - development, manufacturing, and distribution
- Types of Quality System versus applicable GMP Standard(s)
- The meaning of GMP
- Compliance Focus and Product Identity-Safety-Purity-Efficacy
- Fundamental Requirements for GMP
- GMP Basics
- Personnel and Training
- Premises/Facility Control
- Production Areas
- Storage Areas
- Quality Control Areas
- Ancillary Areas and supporting systems
- Equipment Management
- Production and Packaging Control
- Quality Control Functions
- Out-of-Specification Handling
- Overview of Stability Studies
- Good Documentation Practices
- Fundamental GMP requirements for document and record control
- Structure of, and relationship between, GxP documents
- The role of good documentation practices as part of Data Integrity
- Tips for developing SOPs and WIs
- The design and role of Data Collection Forms
- A Quality Systems Approach to GMP
- What is a Pharmaceutical Quality System?
- Quality Risk Management
- Key Quality System Elements for Continual Improvement
- Deviation Handling
- Complaints and Recalls
- Corrective and Preventive Action
- Change Management
- Product Quality Review
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 to update for compliance with current PIC/S GMP, companies that require GMP certification (new/renewal) in PIC/S, or third-party logistics (3PL) providers that repack/reprocess medicinal products.
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.
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.
|Day 1||28 August 2023||8:45am join for 9am-5pm|
|Day 2||29 August 2023||8:45am join for 9am-5pm|
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 $1,400 (excluding tax) per participant
- A 10% discount applies to 3 or more participants from the same company
Course Registration and Payment
To register, please contact Biju Kishor at firstname.lastname@example.org
Contact us to discuss your interest in a public or private delivery of this course.