Addressing and managing deviations is crucial for preventing lost productivity. Typically, investigations into deviations consume significant time and frequently pinpoint human error as a causal factor, leading to the common but often ineffective response of implementing more training or additional procedures. Unfortunately, this approach tends to yield limited success, and issues persist.
This course, focusing on behavioral Good Manufacturing Practices (bGMP), delves into the reasons behind non-compliance with procedures—whether due to error or intentional actions—and explores effective strategies for improvement. Participants will gain insights into three specific modes of human error and understand where "retraining" can be beneficial, but also recognize its limitations in most cases.
Day 2 of the course extends its focus to Data Integrity (DI), a critical aspect in the pharmaceutical industry. Understanding and ensuring the integrity of data is paramount for regulatory compliance and the overall quality management framework. The session will cover key principles, industry guidelines, and practical approaches for maintaining data integrity in various stages of pharmaceutical operations, Quality Control (QC), and all other departments. Practical case studies and real-world examples will be incorporated to illustrate effective strategies for upholding Data Integrity standards. Participants will leave with a comprehensive understanding of how to navigate the complexities of managing data integrity within their organizations.
Day 1 Content
- What causes defective products?
- Understanding the nature of human error
- Sources of Error
- What influences our behaviour?
- Addressing Error
- Stages of Human Learning and Types of Error
- Possible areas that ‘encourage’ human error and eventuate to non-compliance
- Managing Non-Compliant Behaviours
- Building a compliant quality culture:
- Role of Supervision / Management
- Strategies for reducing learning error
- Reducing Inherent Errors and Potential Errors
Day 2 Content
- What does data integrity (DI) mean, who can contribute to good DI?
- Why is data integrity and security such a hot topic for regulators?
- Data criticality and data risk
- Integration of DI into your QMS using a risk-based approach
- Protection and security of raw data and original records
- Developing practical audit and remediation strategies for DI
Participants
Executives, Managers, specialists and supervisors responsible for GMP compliance, reducing deviations,
conducting failure investigations and continuous improvement will benefit from this program
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.
Sessions
| Sessions | Dates | Times |
| Day 1 | 15 July 2024 | 8:45am join for 9am-5pm |
| Day 2 | 16 July 2024 | 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.
Fee
- SGD $1400 (excluding tax) per participant
- A 10% discount applies to 3 or more participants from the same company
Course Registration and Payment of Fee
To register, please contact Biju Kishor at biju.kishor@seerpharma.com.au
Contact us for clarification or to discuss your interest in this course.
