Get ready for an audit (how to train your employees)
Need to get ready for an audit?
How do you ensure your organisation is ready for an audit? Do your employees know how to properly respond to an Auditor’s questions? Or was your last mock GMP audit (or internal quality audit/self-inspection) a disaster? If you’re frightened of what would happen during an actual audit (especially if the audit is unannounced), fear not! We have a new auditing training course that will help your personnel (new and long-term employees), contractors, and vendors, learn how to get ready for an audit.
This new audit-readiness training course includes information on:
- Considerations for planning and conducting a regulatory compliance audit (or self-inspection)
- How to respond to questions from an auditor / regulatory compliance inspector
- Considerations for front room organisation/equipment and backroom management during an inspection/audit
- Audit preparation checklists
- Which records and processes are most likely to be reviewed by a regulatory official
- Why it’s important to ensure your SOPs are current
- How to handle the stress of an auditing experience
This course is suitable for Auditors as well as for organisations participating in an audit, and employees responding to an auditor’s questions.
- This auditing preparation course is designed to assist any person with an audit-related job function, support role, or audit program responsibility.
- It has numerous tips to assist compliance Auditors/Certifiers, Inspectors, Quality Managers, Operational teams and Business Owners, as well as the teams being audited.
Check your employee training records to ensure they are up to date!
GMP industries and other companies must always be ‘ready for an audit’.
Audit preparedness should therefore be a key component of any organisation-wide training program; and not just as an induction training. Ongoing refresher courses are a must.
- Your warehouse and distribution personnel should also be trained in regulatory compliance, as relevant to your industry, supply chains, and product lines.
- This online training course is also helpful to remind Quality Management teams to ensure their employees’ training records are up to date, as well as their Organisational Charts, Competency Assessments, SOPs, and floorplans.
You must always be ‘ready for an audit!’
Few companies manage to be “audit ready” all the time. And a number of companies fail to implement ‘mock audits’ on a frequent enough basis to understand the gaps in their quality management systems or PQSs.
These are highly likely items for potential citations/fines during an actual audit — especially a surprise one!
In fact, one of the most frequent audit findings (citations) is NOT being audited ready and NOT having employee’s properly trained in regulatory compliance.
Note: This course suits Auditors as well as Auditees as it contains tips for both the Auditor/Regulatory official and the Auditee (organisation being inspected).
How to get ready for an audit – eLearning modules
A new online training course to get your employees and contractors ready for an audit.
To train your employees, contractors and other stakeholders in GMP audit preparations, we’ve recently published a new online training course, Preparing for an Audit.
This complements our other two training courses for Auditors and Auditees; including remote auditing considerations and remote auditing procedures and techniques.
Is this ‘audit readiness’ training course suitable only for GMP employees, or is it good for other industries?
This online training course is suitable for a variety of audit types and industries, including but not limited to:
- Getting ready for a PIC/S GMP audit conducted by regulators, e.g.
- ISO Certification audits
- ISPE audits for drug manufacturers
- Mock audits of regulatory compliance (e.g. GMP compliance ‘mock audits’)
- Self-inspections
- Recordkeeping audits (documentation audits / ALCOA+)
Click here for more information on the “Preparing for an Audit” online training course including tips for answering Auditor’s questions, tips for Auditing personnel and Regulators, and handy ‘audit preparation’ checklists.
Suggested reading: Remote auditing trends and increases in remote inspections in the wake of the global pandemic.
Prepare your team for an audit / regulatory inspection.
Need to prepare your team for an audit?
Get your team members to complete this online training course in ‘audit preparation’, suitable for a variety of regulated sectors.
Last updated on July 6th, 2023 at 10:30 am
