Remote Auditing

Remote Auditing

USD $30.00

Course duration: Allow 1.5 to 2 hours to complete this course.

Description

Remote Auditing techniques and guidelines

Remote auditing training course for planning and conducting ‘offsite inspections’.

Remote auditing is on the rise. But conducting a remote audit/inspection requires risk-managed auditing strategies and thoughtful planning.

  • Overall, these types of audits have recently expanded in scope and volume.
  • New ICT capacities (internet and communication technologies) are also available to auditors and auditees.
  • But these can lead to file-transfer security issues that must be addressed.

Fortunately, this new online Remote Auditing techniques training course will help you understand how to improve your remote auditing capacity, procedures, and interviewing strategies.

It is designed to assist Regulators, Auditors, Quality Managers and Auditees in planning, conducting, participating in (or refining) remote auditing procedures to ease the process. This Certificate course is available to access (online) immediately upon completion of our online order. Check your email folders for log-in instructions after your course purchase is complete.

Growth trends in remote auditing procedures

“Remote auditing” has long been used to assess the capacities of overseas suppliers in the Pharmaceutical and Medical Device sectors.

  • But the global pandemic is restricting site visits and hence, limiting onsite auditing opportunities for regulators and contract holders.
  • These travel restrictions are coinciding with a growing demand for medical products.

The combination of (a) restricted auditing opportunities and (b) higher demands for medications/medical supplies (such as masks and respirators) increases the risk of harms to global public health, practitioner safety and patient healthcare outcomes.

This higher demand for medical products and pharmaceutical products — along with interruptions to medical supply chains and many new manufacturers attempting to enter the global supply chain — makes delays in auditing schedules a very dangerous affair (for public health).

Travel restrictions and employee safety are now key considerations for audit planning in the current climate.

  • Travelling to conduct an onsite audit simply places Regulatory Auditing personnel, Inspectors and manufacturing personnel at too great a risk.
  • This has led to remote auditing becoming the ‘go to’ auditing method for compliance audits
  • Particularly when auditing schedules would otherwise:
    • fall significantly behind schedule
    • place public health and safety at risk

 


Remote Auditing is an important option for keeping auditing schedules on track, particularly when it comes to GMP sectors. But remote inspections / offsite auditing procedures must be risk-assessed.


Demand for pharmaceutical products and medical devices is skyrocketing across the globe.

  • New products are being developed to help ease the impact of the pandemic.
  • New manufacturers are entering global supply chains and several countries are expanding their own manufacturing capacities to meet the increases in domestic product demand

This means learning remote auditing techniques is a necessity for Auditors, Regulators, 3rd party auditors, Organisations and Auditees (Quality Managers, Department Managers, and their production and distribution teams).



Remote Audits and Remote Interactive Evaluations


 remote auditing proceduresguidelines.


This Remote Auditing training course is suitable for Auditors conducting remote audits. It is also ideal for Auditees who are participating in a remote inspection.


Remote Auditing techniques and tips from auditing experts

remote auditing guidelines GMP FDA guidance remote inspections audits GMP regulations or TGA guidelines remote auditing

Our new course on Remote Auditing techniques and procedures was informed by:

    • Regulatory guidance publications
    • Industry experts on regulatory compliance audits
    • PQS managers

Who should complete this Remote Audit techniques/procedures training course?

This course is suitable for any professional and industry where remote audits are conducted; with additional sections specifically designed to assist GMP professionals including Auditors, Regulators, and Auditees.

Anyone involved with auditing, either as an Auditor or Auditee, is likely to benefit from this course, which covers basic and advanced techniques for remote auditing.

The course also includes remote auditing procedures and helpful ‘remote inspection tips’ gleaned from top Pharmaceutical Industry auditing experts and Quality Managers.


About this Auditing Training (New course on Remote Auditing Techniques and Procedures)


remote audits remote auditing guidelines fda tga gmp


Opportunities and Challenges during Remote Auditing or offsite inspections

Need to learn more about remote auditing techniques and procedures?

  • This Remote Auditing of regulatory compliance training course provides an overview of considerations that Auditors and Quality Teams should take into account when planning and conducting an offsite audit or remote inspection.
  • The course details types of remote auditing methods (such as hybrid auditing methods) and ICT considerations including data security and file transfer considerations.

Requirements and procedures for conducting a Remote Audit or Remote Interactive Evaluation of compliance matters.

The course is ideal for Government Regulators, Quality Management teams, Department Managers, Administrators and other individuals responsible for conducting internal audits and/or external audits of regulatory compliance and other standards.


Remote Auditing Guidelines and Remote Inspection Techniques

Questions this Remote Auditing Techniques training course helps answer:

  • What do Regulatory Authority auditors and other Inspectors and Investigators need to know in order to conduct a Remote Audit successfully?
  • What are the benefits of conducting remote audits vs onsite inspections during a global pandemic, when onsite auditing is risky to Auditors and other personnel (or travel to certain manufacturing regions is prohibited)?
  • What are the Information and Communication (ICT) technologies to consider?
  • What opportunities and risks arise when relying on remote auditing technologies?
  • How do you determine the auditing scope?
  • What about following up (and future audit requirements)?
  • What are your options for auditing when an offsite audit isn’t suitable?

This Remote Auditing Techniques training course will help Auditors understand:

  • How to plan, prepare for and perform a remote audit or remote interactive evaluation
  • Best practices for performing remote audits (remote audit procedures and checklists)
  • How to determine if a remote audit is likely to meet the auditing objectives
  • The challenges, opportunities of various ICT used to conduct an audit
  • Data security issues and IT considerations for remote audits
  • Challenges of video-based site inspections and other digital technologies
  • Regulatory Guidance for conducting a remote audit including IAF MD4
  • The importance of documented risk assessments and confidentiality/security agreement
  • Technological challenges and ICT issues to consider
  • File sharing permissions/web-based access and system compatibility issues
  • Security and data breach risks that may be posed by remote audits and ICT
  • Additional content that must be included in a remote audit report

The events of recent years resulted in a substantial increase in Remote Audits (the TGA’s term) and Remote Interactive Evaluation (the FDA term).  To address the gap in knowledge of performing a remote audit in this industry, our new course will help you learn how to prepare for a remote audit, including ICT and data security considerations.


FDA guidance on remote inspections/remote audits

April 2021 FDA news release (RIE)

FDA guidance (April 2021) on remote inspections/ Remote Interactive Evaluations (GMP compliance audits).

  • The FDA recently published non-binding guidance to help the pharmaceutical manufacturing industry implement remote auditing procedures.
  • Other Regulators from numerous countries are currently working together to develop globally accepted guidelines for conducting Remote Audits of GMP compliance with PIC/S GMP regulations and other standards, including ISO.

Course Duration:  Allow 1.5 to 2 hours to complete this training course including the online assessment.