Regulatory Inspection Preparation Training Course

• 2-Hour Training Course 
• Webinar or Face to Face (F2F) Learning
• Expert Trainer With Actual Regulatory Inspection Experience in Life Sciences

This 2-Hour interactive course aims to provide the knowledge and skills required by employees to conduct themselves appropriately and confidently during a regulatory inspection, in-front of an inspector.

By completing this course, employees will be better prepared to handle regulatory inspections confidently and competently, ensuring compliance and minimising the risk of adverse findings.

Learning Outcomes

In this course employees will learn about essential concepts and practices to equip them with the skills and knowledge on how to handle interactions with inspectors professionally and effectively.

Understand the inspection process:

• Gain familiarisation with the stages of a Regulatory Inspection.
• Learn the roles and responsibilities of both the inspection team and the your organisation’s staff.
• Learn how to efficiently retrieve and present requested documents and records.
• Understand the importance of maintaining the integrity and organisation of documents.
• Understand the importance of adhering to SOPs during the inspection.
• Recognise and avoid common pitfalls, such as showing unrequested documents or making unofficial statements.
• Learn how to effectively manage and coordinate the inspection process.
• Understand the role of an escort and the importance of monitoring the inspectors' activities without obstructing their work.
• Learn how to prepare for and participate in the exit meeting.
• Understand the importance of taking detailed notes on inspectors’ observations and feedback.
• Practise discussing and clarifying any observations or potential non-compliance issues identified during the inspection.

Learn how to conduct yourself during an inspection:

• Understand the importance of professionalism, courtesy, and respect when interacting with inspectors.
• Develop the skills in clear, concise, and honest communication.
• Practise listening carefully to inspectors' questions and answering directly and accurately without volunteering unnecessary information and avoiding speculation or assumptions.
• Understand the importance of non-verbal communication, such as body language and eye contact.
• Know when to escalate questions to more knowledgeable personnel if the answer is not known.
  

Target Audience

This course will be of great value to anyone currently working in the Life Science Industry, or any other highly regulated and proceduralised industry that is subject to regulatory inspections.

Examination

The course is concluded with an optional examination.