Course Code: CPD/O/10/2021

CPD Hours: 14

Day 1 Supply Chain Management
The provision of medicines is a global business with active pharmaceutical ingredients, components and products being sourced using increasingly complex supply chains. Recognising the limitations of regulatory oversight by individual countries, the US Government passed the Drug Supply Chain Security Act (DSCSA) as legislation requiring a national track-and-trace system for medicines and electronic tracing of production through the supply chain; enforced by the FDA from 01 May 2015. The EU has also enhanced their GDP requirements, and these have been in place for some time. These actions reinforce the need for all personnel in your organisation’s supply chain to understand their role and work to implement and maintain a robust and comprehensive quality system. The application of risk management principles within this system will help your organisation safeguard the quality and supply of product to your customers.

Day 1 Content

You will develop a detailed understanding of the principles of responsible supply chain management and a framework for implementation and improvements. Specifically, you will learn the principles and practices of Quality and Risk Management Systems that you need to ensure the integrity of your supply chain, including:

  • Management responsibility
  • Regulatory and customer requirements: current and future
  • Maintaining the cold chain
  • Process control and validation
  • Good documentation and record keeping practices
  • Training
  • Continual improvement

Global Supply Chain

Day 2 Building A Successful Supplier QA Program – A Strategic Approach
You will be be provided with an overview of the current regulatory requirements and expectations, along with a 6-step plan for managing your supplier quality so you can start reducing your supplier risks and improving your compliance.

Day 2 Content

You will get an appreciation for:
  • Recent changes and enforcement trends in regulatory requirements for supplier management
  • SOPs and records needed for compliance and to prove effective supplier qualification.
  • 6-step planning for managing supplier quality
  • Identifying supplier risk factors
  • Establishing supplier risk ratings and evaluation criteria
  • Structure and content of the Supplier Quality Agreement
  • Reduced testing considerations
  • When the supplier is part of your organisation – Quality Agreements and the role of QA

Participants

This course is for you if you have a level of responsibility for the quality and/or integrity of your organisation’s supply chain, specifically in relation to the procurement, supplier quality assurance, distribution and logistics of sourcing and supplying finished pharmaceuticals, pharmaceutical ingredients, and medical devices.

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  12 September 2022  9:00am-5:00pm
 Day 2  13 September 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

Shruti Narayana

Shruti has over 15 years of rich experience in quality management in the pharmaceutical industry with reputable companies in Southeast Asia and India and extensive experience in setting up and managing quality systems for manufacturing, packaging & distribution of pharmaceutical products assuring high quality standards as well as regulatory compliance. Shruti also has a comprehensive understanding of all aspects of quality management including manufacturing, validation, documentation, technology transfer, investigations, complaints, product recalls & returns, change control and product quality reviews as well as software packages like TMS quality compliance software, Blue Mountain calibration & maintenance software and QS Doc electronic documentation management system. Shruti can collaborate with management teams and contribute to the development of new products, engineering designs, manufacturing & training methods for continual improvements in quality & productivity. Shruti can communicate in Hindi.