Course Code: CPD/O/07/2021

CPD Hours: 14

Day 1 Managing Internal Audits
Internal audits are a fundamental part of implementing, maintaining, and improving your quality system which is critical to your business’ success. Whether you work for a pharmaceutical company complying with “self-inspection” requirements of the PIC/S Guide to GMP, deploying an internal audit program throughout your organisation will help educate personnel, confirm ownership of various quality system elements, and ultimately drive continuous improvement and cost reductions.

Day 1 Content
  • Critical role of quality audits in compliance & improvement
  • Regulatory standards and guidelines for quality auditing
  • GMP and QS requirements for internal audit programs
  • Risk Assessment as it applies to quality audit practices
  • Documents, records, and data for effective audits
  • Audit schedules and the use of risk management in relation to prioritising audits
  • Techniques and tips for auditing - 6 fundamental steps of auditing]
  • Examples of audits observations cited and group discussion

Asian GMP Operator with yellow tablets

Day 2 Managing External Audits
Regardless of whether you are expected to speak with the regulator(s) or to work behind the scenes gathering requested documents and records, this course will address the key areas that you must focus on when preparing for a regulatory inspection. It will dive into the differences between approaches of the US FDA, EU, and TGA, and how to best handle responses to observations / findings from a GMP Inspection. Differences you will encounter in remote inspections (compared to on-site inspections) will also be covered.

Day 2 Content
  • Legal requirements of inspections and some differences between International Inspectors
    • Access to site
    • Collection of evidence including photographs
    • Viewing of internal inspection reports
  • Things to get ready
  • Remote Inspection vs Onsite
  • “War Room” protocol
  • Using Subcontractors and Knowing the Starting Point of Manufacture
  • Preparation for New Licence vs Routine Re-Inspection
  • Opening Meeting, Daily Wrap Up and Closing Meeting
  • Closeout
  • Examples of audit observations cited and group discussion
Participants

This course is designed for all operational staff who are involved in audits, for example, Quality Assurance, Quality Control, Manufacturing, Validation, and Engineering personnel.

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

Participants will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  25 July 2022  9:00am-5:00pm
 Day 2  26 July 2022  9:00am-5:00pm

Seats are limited: Only 25 participants per class

Fee and Registration
  • HKD $4800 per participant
    • A 10% discount applies for 3 or more participants from the same company

To register, please contact Biju Kishor at Biju.kishor@seerpharma.com.au 

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.