Dr Martin M. Appel, Cilag AG/Johnson & Johnson
Richard M. Bonner, ECA, form. Eli Lilly
Dr Jean-Denis Mallet, form. Head of the French Pharmaceutical Inspection Department (AFSSAPS
Frank Raisch, GSK
John Taylor, form. U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)
Mark Tucker, Ph.D, form. US FDA Investigator and Compliance Officer
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 Inspection
- The psychology of inspections
How legal department can support
In addition you will hear trends from EU and FDA
Inspections to gain a better understanding of what is expected.
Sufficient time for questions and answers is provided to discuss your issues.
GMP audits and inspections are fundamental elements of managing quality assurance 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 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.
Note: The number of participants is limited.
As a participant you will get a detailed checklist for inspection preparation (40 pages). This checklist can be adapted to prepare your pre-approval inspections, routine inspections or customer audits.
In addition, you will get the GMP Navigator CD-ROM. This CD contains all relevant EU, FDA, ICH, and WHO guidelines. In the office or on the laptop during inspections, the CD-ROM is a useful tool for verifying, for example, whether a particular requirement is really laid down in the guidelines or not.
The Challenges of GMP Audits and Inspections
Authority Expectations: some practical Examples from a former EU Inspector
- Regulatory requirements
- Purposes and reasons for GMP inspections
- Audit types
The View of a former MHRA Inspector
- Organisations, agencies and inspections worlswide and their differences
- Experiences from an ex-inspector’s point of view
- What to expect when being inspected in the near future
The View of a former FDA Inspector
- Quality management systems and their assessment
- Improvement through auditing and benchmarking
Typical Compliance Issues
- The FDA Inspection System
- Classification of GMP deficiencies/Examples of critical deficiencies
- FDA inspection findings
- What does the inspector expect when he arrives at your site
- What the FDA will look for
- PAI vs. System Inspection
- What happens at FDA during and after the Inspection
- Responding to FDA (483, Report, Warning Letter)
- Hot topics and trends in the agency that will result in future GMP guidance updates
How inspectors are trained
- Quality System
- Laboratory control
- Material Management
- Facility & Equipment
- Packaging and labelling
The MOCK Inspection: Auditing Your Company to prepare for international Inspections
- What makes a good Inspector
- Skills needed
- Information transfer between inspectorates
Preparation and Management of Regulatory Inspections
- Internal audit expectations
- Audit hierarchy
- EU and FDA cGMP differences
- Quality System audit details
- Audit strategy and cycle
- Rolls and Responsibilities
The Psychology of Inspections
- Tools to successfully manage regulatory inspections
- Features of on-line communication tools, e.g. NetMeeting, WebMeeting
- Layout of the Back Room
- Inspection workflow and definition of functions
- Docket system
Case Study: The juristic Perspective - how legal Department can support QA
- Who is in charge?
- How to deal with conflicts
- What if you don’t agree with an inspector?
- Body language of inspector and auditee
- Some “tricks of the trade”
- The Dos and Don’ts
- Direct Inspection Support
- Replies and Response to Inspection Reports
Proactive Compliance and Inspection Management – it’s more than Self Inspection
Case Study: An Inspection Management Risk Model
- How to increase inspection risk-awareness
- Risk categorisation and ranking
- Risk reduction prioritization
- Reporting of the results to senior managemen
You will be able to attend two of these parallel sessions. Please choose the 2 sessions you would like to attend when you register for the course.
Preparing for a Regulatory Inspection (with Inspection Simulation)
Gap analysis and action plan
Roles and responsibilities
Training of the staff
Function of moderator, escorts and experts
The workshops includes a simulation of an inspection situation (role play).
Risk Analysis related to the Inspection and Findings
Conceptualisation of the “Risk”
What is an inspection / audit finding
Quality Risk Management & GMP Findings
Know your GMPs
An interactive review of different GMP scenarios which will take into account your knowledge of GMPs and enable detailed discussions on the implications of the actions taken.