Managing your deviations contributes to lost productivity. Investigations consume considerable time and often identify human error as a cause, resulting in more training or more procedures. Frustratingly, this approach rarely works and problems persist.

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This course on behavioural GMP (bGMP) examines why people don’t comply with procedures, either by error or perhaps deliberately, and what can be done about it. You will learn about THREE specific modes of human error and where “retraining” can actually help; but why it doesn’t most of the time.

Content

Within the context of a GMP organisation, we’ll examine:

  • What is important to the person doing the work (and therefore how they will behave)
  • How people learn and what sort of errors they commit at each stage of learning
  • How the culture of the organisation itself influences behaviour
  • The importance of systems in influencing and supporting changed behaviour
Participants

Managers 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 can be delivered as 2 x 3.5 hour sessions over 2 days or as 1 full day session. Breaks are included.

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.

PDF Certificates will be provided to participants electronically.

Sessions

Participants will attend both half-day sessions:

 Sessions  Dates  Times
 Day 1  21st October 2021  8:45am join for 9:00am-12:30pm
 Day 2  22nd October 2021  8:45am join for 9:00am-12:30pm

Times are based on Melbourne, Australian Eastern Daylight Time (AEDT) / Coordinated Universal Time (UTC) +11:00.

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee and Discount
  • AUD $600 (exc. GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

Register Now By Online Credit Card Payment

Contact us for clarification or to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions

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Proposed Trainer

Smitha Kenchath

Smitha has over 20 years of experience in the Pharmaceutical and Biotech industries that includes established MNCs and start-ups with specific experience in Quality Assurance and Quality control. Having setup Quality Management Systems and Analytical Laboratories for various industries such as APIs, radiopharmaceuticals and biologics, Smitha has extensive experience in technology transfer, laboratory information management system implementation, GMP certification, supplier quality assurance, documentation management, materials management, training management, investigation management, equipment qualification and validation. Smitha has also assisted and hosted various regulatory audits that includes FDA, EU GMP, H.S.A. and various third-party audits. In her current role at SeerPharma, Smitha is involved in various projects consulting, developing and delivering training programmes.