Preparing for an Audit

Description

Preparing for an Audit: online training course

Preparing for an Audit: online training course

This online training course “Preparing for an Audit” will suit Auditees as well as Auditors, including Regulatory Authority inspectors who need a refresher course on the art of auditing and how to prepare for an upcoming audit or site inspection.

• The “Preparing for an Audit” certificate training course is available online.
• You can start your auditing preparation training immediately upon completion of your online order.

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The course is designed to help Auditees and Auditors prepare for an upcoming site inspection or compliance audits, such as when making an assessment of compliance with ISO guidelines, PIC/s GMP regulations, ISPE guidelines, and more.

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Preparing for an Audit (for Auditees and Auditors)

This course provides a high-level overview of the following audit planning and audit preparation components.

• Regulations and types of audits including regulatory audits and self-inspections
• Audit planning criteria
  • how to prepare to conduct an audit (tips for Inspectors/Auditors)
  • how to prepare for being audited (tips for Quality Managers, Auditees and Personnel)
• Importance of knowing the specific Codes and Regulatory standards (PIC/S GMP, ISO, ISPE, CFRs, etc) referred to during different types of audits
• Risk assessments, critical elements of an audit, and auditing time constraints
• Audit Process Overview and use of ISO 19011:2018 Guidelines
• Audit preparation including roles and responsibilities
• Audit day activities
• Audit findings (common FDA citations/audit findings and breaches of GMP)
• Auditing reports, & post-audit follow-up
• Questioning types
• Tips for Auditees (Quality Managers and other personnel being interviewed during a compliance audit)
• Findings from recent GMP audits conducted by the FDA

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Who should take the “Preparing for an Audit” training course?

This online audit preparation course “Preparing for an Audit” will suit a majority of professionals with responsibilities for quality assurance, from Auditors and Regulatory Inspectors to Quality Management teams to personnel assisting with the Audit.

• This course is suitable for a variety of sectors/industries.
• This audit preparation course is designed to assist Quality Management teams, personnel/contractors and suppliers, Auditors and Inspectors, Report writers, Operations Managers, Business Owners, Human Resource Managers, and others with responsibilities for regulatory compliance (various industries including but not limited to GMP sectors).
• This auditing preparation training is also valuable for a wide variety of employees needing Audit training/audit preparation tips, auditing preparation resources, and helpful auditing checklists.
• A Certificate of Completion is available on successful completion of this Preparing for an Audit cGMP training course (online).
• The training Certificate can be saved, printed, and attached to your CV and personnel records.

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Audit preparation checklists and training courses

This online audit preparation training course is designed for a variety of auditing situations, sectors and job roles.

It offers helpful planning tips for Auditors/Inspectors and Auditees/Quality Management personnel and business owners.

The course will suit learners regardless of whether they are participating in an audit, or conducting the audit or inspection. It is suitable for situations where audits are being conducted by an external Regulator (ISO auditor/ISO compliance inspector, FDA regulatory auditor, TGA regulatory auditor or similar); an internal Quality Manager (conducting a Departmental Audit or self-inspection); a contract giver/manufacturer performing a supplier audit or a supplier being audited by the contract holder; or various other types of audits and inspections.

For remote auditing techniques, click here.

This audit preparation training course (online) is suitable for a variety of industries and audit types, including but not limited to GMP compliance audits, ISO certified organisations, ISPE manufacturing audits, FDA or TGA audits and other types of inspections.

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GMP compliance audits: how to be prepared

• This training course is also suitable for GMP compliance audit preparations in pharmaceutical manufacturing sectors (and is suitable for Auditors and Auditees), as well as other types of auditing and other Codes and Standards (for example, ISO standards).
• It will assist PQS teams and manufacturing employees of various product types to prepare for audits, including organisations subject to frequent regulatory compliance audits (or unannounced inspections) by regulatory groups such as the FDA (USA), TGA (AUS), EMA (EUROPE), MHRA, and others.
• The course references quality management of raw materials, API suppliers, batch recordkeeping requirements/documentation standards, distribution practices, and more.

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Prerequisites: N/A

This course is for Education Purposes only. It should be implemented alongside adequate onsite training, product-specific compliance training, and appropriate Supervision.

Recommended courses: Introduction to Auditing

Subsequent training course: Remote Auditing

Further reading/resources:

Who conducts GMP audits in the pharmaceutical sector?

Remote auditing statistics – why is remote auditing so common in the post-covid/post-pandemic era

List of Regulatory Agencies conducting audits in the Pharmaceutical Industry.