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 or a medical device company complying with “internal audit” requirements of ISO 13485, 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.

quality team reviewing documents in an internal audit or self inspection

Internal audits deliver value irrespective of how mature your organisation’s quality system is.

Do you need help optimising and delivering more value from your self inspection / internal audit program? This course can help you achieve your KPIs.

Content

You will learn and practise techniques for preparing audit plans, performing audits, verifying observations, reporting and implementing Corrective and Preventive Action (CAPA) from a range of lessons within the following  two main topics:

  • GxP and Quality Auditing
    • Critical role of quality audit in GMP compliance & improvement
    • Regulatory standards and guidelines for quality auditing
    • GxP requirements for internal audit programs
    • Risk assessment as it applies to quality audit practices
    • Documents, records & data for effective audits
    • GxP audit schedules and the use of risk management in relation to prioritising audits
    • Six fundamental steps of auditing explained in detail (including tips on how to manage & facilitate audits in a constructive manner)
  • Corrective and Preventive Action (CAPA) and Auditing
    • Defining Corrective and Preventive Action (CAPA)
    • Overview and systematic application of the CAPA system as it applies to quality audits
    • Relationship between CAPA and risk assessment / management
    • Risk assessment / management as it applies to audit scheduled and observations
    • Application of CAPA to audit observation deficiencies
Participants

This course is designed for operational personnel (key operators, supervisors and managers) who have a key role in quality systems implementation and will assist them to develop a system of quality audit.

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 is generally 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

Each participant will attend both full-day sessions:

 Sessions  Dates  Times
 Day 1  9th June 2021  8:45am join for 9:00am-5:00pm
 Day 2  10th June 2021  8:45am join for 9:00am-5:00pm

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

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

Fee and Discount
  • AUD $1,200 (excluding GST) per participant; introductory offer
    • A 10% discount applies for 3 or more participants from the same company

New Session To Be Advised

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

Refer to the Terms and Conditions

Jo Sherriff Circle Gradient Grey BG 182x182

Proposed Trainer

Jo Sherriff

Jo is an experienced senior compliance engineer, responsible for developing and executing GMP validation documentation, including validation plans, specifications and qualification protocols. She has experience in cleanroom compliance, equipment compliance, system compliance, as well as cleaning validation and process validation. Jo is also responsible for developing and executing non-GMP regulatory compliance documentation, including project verification plans, verification protocols, site check lists and reports. Jo has a range of regulatory compliance experience - TGA, FDA, DAWR (Biosecurity), OGTR, ARPANSA, SSBA, and Pharmacy Board of Australia, SHPA, PRASA - and is therefore familiar with the relevant regulatory standards and codes - PIC/S, FDA, EU, WHO, ISO, ARGB, AS/NZS. Jo is an experienced presenter of Validation Workshops and Training for inhouse staff, clients and building contractors. She is experienced in development and presentation of Quality Assurance Procedures and conducts Quality Assurance Audits. Jo is a qualified senior chemical engineer with a diverse background in the pharmaceutical and biological industries.