In this Live Online training course you will learn
How to plan and conduct audits efficiently
How to face the various challenges
What communication techniques are needed
How you can avoid and solve conflicts
Best practices for audit report writing
Background
Initial and continuous professional training for auditors is of utmost importance as the authorities expect highly qualified personal performing audits. Therefore, the ECA has developed the programme at hand to give you a detailed overview about important matters to consider and to discuss important tasks and challenges like:
Expectations of the authorities
Audit types
How to deal with travel restrictions
Risk-based audit planning
Audit plan and audit team
Audits in China, India and South America
Categorisation of audit findings
Audit report writing
Communication Skills
Conflict solving
Target Group
GMP-Auditors from Pharmaceutical and API Industry.
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Community project: evaluation of supplier Audits in Europe
Who needs to be audited
Things to consider when setting up a risk-based Audit Programme
GMP Certificates and CEPs
Third Party, Joint- and Shared Audits
Expectations of the authorities
Examples: what can go wrong
How to plan an Audit
Preparing your audit Programme - Criteria for setting priorities - Resource planning
Setting and agreeing audit objectives
Selecting auditor team and assigning objectives to Auditors
Defining roles in an audit Team
Performing the audit and monitoring Progress
Summarising the findings and how to feedback to auditees
Follow up and closing the loop
Hybrid Audits: Distant Assessments and the Combination with on-site Audits
Distant Assessments as part of the overall supplier qualification System
Possibilities and limits of Distant Assessments
Distant Assessments in combination with on-site Audits
Tips for technical implementation
Case Studies: Categorisation of various Audit Findings
Examples of audit situations and findings
How to evaluate the given examples
Possible follow-up activities
The Auditor – what makes you a good Auditor
Auditor Training
How to become a good Auditor
Essentials Auditor Skills
Auditor pitfalls and how avoid them
Communication Skills
The challenge of appropriate communication
How to recognise, understand and solve conflicts
Body Language
Questioning Techniques
Suppliers from China, India and South America
How to prepare audits abroad
Challenges and pitfalls
Typical compliance issues: what to look for
Cultural particularities
Audit Report Writing
How to take proper audit notes
Best practices for audit report writing - Using standardised report templates - How to generate a clear and concise list of findings - Phrases that should be avoided - Purpose and conclusion
When is a report final?
Timelines for finalisation, distribution, feed-back and follow-up
Difference between internal and external audit report
Question and Answer Sessions A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your questions.
This course is part of the GMP Certification Programme "ECA Certified GMP Auditor" Learn more
Testimonials
Seminar Programme as PDF