This GMP Education Course is designed for all persons involved in preparing, managing and escorting audits and inspections.
Objectives
You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.
Get practical knowledge of:
What inspectors are looking for
Successful preparation and management of inspections
Performing a MOCK-Inspection
Latest trends (with a view on virtual/remote inspections)
In addition, you will hear examples from global inspections to gain a better understanding of what is expected.
Background
GMP audits and inspections are fundamental elements of managing quality in the pharmaceutical industry. On the one hand, pharmaceutical companies have to perform supplier audits. And on the other hand, the pharmaceutical companies as well as the suppliers are frequently inspected by the authorities (both national and international inspectorates like the FDA) as a central element of supervision.
For the company, an inspection can have a decisive influence on the daily work and its economic future. A sound and thorough preparation is an essential key to successfully pass an inspection
Programme
Approach and Expectations of the Agencies
How inspectors are trained
Skills needed
Inspection preparation, strategy and tactics
Information transfer between inspectorates
What to expect, when being inspected in the near future
Observations - some practical examples
Preparing for a Regulatory Inspection
Team building
Gap analysis and action plan
Roles and responsibilities
Training of the staff
Function of moderator, escorts and experts
Case Study: Proactive Compliance and Inspection Management – it’s more than Self Inspection
How to increase inspection risk-awareness
Risk categorisation and ranking
Risk reduction prioritization
Reporting of the results to senior management
The MOCK-Inspection: Auditing your Company to prepare for international Inspections
Internal Audit and Mock-Inspection
Audit strategy
Roles and Responsibilities
Communication and co-operation
Sequence of preparation steps
Co-operation with customers and external auditors
Expectations from Inspectorates worldwide
Brazil (ANVISA)
Mexico (COFEPRIS)
Turkey (MOH)
Russia (FSI SID&GP)
Eurasian Economic Union (EAEU)
China (NMPA)
South Korea (MFDS)
Taiwan (TFDA)
The FDA Approach
The MRA between the U.S. and the EU and its consequences
The FDA Inspection System
What does FDA expect?
Responding to Audit and Inspection Findings
How to reply to report and observations
Dissent and Dispute
Proof of CAPA effectiveness
Ensuring that measures are implemented company-wide
What to do if a target date can not be achieved?
Further Information
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Testimonials
