• Are you involved with any authorisation step in manufacturing GxP regulated product?
  • Do you need to be aware of the responsibilities of Authorised Persons?

If you answered “yes” to either question, this course will help you understand and execute your Quality / GMP responsibilities so that you and your organisation release product to market in compliance with the marketing authorisation.

Quality-Assurance-Manager-Working-at-Desk

Content

As regulators increase their attention on release for supply processes and personnel, SeerPharma is supporting industry with this dedicated Release for Supply training course. You will learn the duties and responsibilities of Authorised Persons within the context of the Australian regulatory framework and improve your understanding of critical areas including:

  • An overview of the regulatory requirements
  • Batch Review and decision-making on disposition
  • GMP and Quality Agreements and the role of auditing and monitoring
  • Risk-based approach: Critical Quality Attributes (CQAs) & Critical Process Parameters (CPPs)
  • Case study: Using the traffic light system

This course addresses:

  • PIC/S Guide to GMP version 14 (PE 009-14)
    • currently adopted by the TGA (01 July 2020) and Medsafe (03 May 2021)
  • TGA Guidance on Release for  supply of medicines (February 2019)
Participants

This course is suitable for all personnel with any level of responsibility for releasing regulated products for supply. You may have the final signature or be responsible for authorising some steps in the manufacturing process. You might be involved in quality-related investigations, or need to better understand the obligations of the manufacturer or the sponsor. People from the following functional areas have benefited from this program:

  • Quality / Quality Assurance / Quality Control
  • Production / Manufacturing / Packing
  • Third Party Logistics (3PL)
  • Suppliers
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 x 3.5 hour sessions over 2 days. Breaks are included.

A digital credential (badge) will be issued via Credly on e-mail to recognise successful training completion.

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 half-day sessions:

 Sessions  Dates  Times
 Day 1  19th September 2022  9:00am-12:30pm
 Day 2  20th September 2022  9:00am-12:30pm

Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Fee and Discount
  • AUD $700 (excluding 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