Alexander Kammerlocher, GMP/GDP Inspectorate, Local Government, Germany
Katja Kotter, Vetter Pharma-Fertigung, Germany
Edel Ryan, Bristol Myers Squibb, Ireland
Dr Ralf Schreiner, QProgress, Germany
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
- Typical compliance issues and proactive compliance
- Performing a MOCK Latest trends (with a view on virtual/remote audits)
In addition you will hear examples from global inspections to gain a better understanding of what is expected.
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.
This GMP Education Course is designed for all persons involved in preparing, managing and escorting audits and inspections.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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?
How to prepare for Distant Assessments/ Hybrid Inspections (the Auditee’s Perspective)
- Tools needed
- Which documents can be provided upfront – and how
- How to realise a safe document Review
- How to support a virtual tour
- What problems can occur and possible solutions
- Resources and time requirements
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?