The Challenges of GMP Audits and Inspections
- Regulatory requirements
- Purposes and reasons for GMP inspections
- Audit types
The View of a former EU Inspector:
Authority expectations - some practical examples
- Organisations, agencies and inspections worldwide and their differences
- Experiences from an ex-inspector’s point of view
- What to expect, when being inspected in the near future
What makes a good Inspector
- How inspectors are trained
- Skills needed
- Inspection preparation, strategy and tactics
- Information transfer between inspectorates
The View of a former FDA Inspector:
- The MRA between the U.S. and the EU
- The future of FDA inspections
- FDA inspections despite MRA
- What FDA will expect from EU sites
- FDA’s Quality Metrics Initiative
- The FDA Inspection System
- Classification of GMP deficiencies/Examples of critical deficiencies
- What does the inspector expect?
- PAI vs. system based inspection
- What happens at FDA during and after the Inspection
- Responding to FDA (483, Report, Warning Letter)
- Hot topics and trends
Experiences with various Inspectorates (what you need to know)
- Brazil (ANVISA)
- Mexico (COFEPRIS)
- Turkey (MOH)
- Russia (FSI SID&GP)
- Saudi-Arabia (SFDA)
- Taiwan (TFDA)
Typical Compliance Issues
- Quality System
- Laboratory control
- Production
- Material Management
- Facility & Equipment
- Packaging and labelling
The MOCK-Inspection: Auditing Your Company to prepare for 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
Workshop:
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 management
Preparation and Management of Regulatory 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 can support QA
- Preparation
- Attendance
- Direct inspection support
- Replies and response to inspection reports
The Follow-up
- 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
Parallel Sessions
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.
Session 1
Preparing for a Regulatory Inspection (with Inspection Simulation)
- Team building
- Gap analysis and action plan
- Roles and responsibilities
- Training of the staff
- Function of moderator, escorts and experts
The workshop includes a simulation of an inspection situation (role play).
Session 2
What would you do if … (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.
Session 3
Data Integrity
- GMP process and laboratory data flow
- Preparing and presenting data sources and data governance for an inspection