All participants receive a Checklist for FDA Inspection Preparation
Target Group
Personnel involved in audit and inspection preparation, management and hosting.
Objectives
You will gain a clear understanding of the purpose and organisation of regulatory inspections and learn how to prepare your company for inspections and customer audits. You will also discover how to manage these activities effectively and maximise the likelihood of a positive outcome. You will gain practical insights into:
What inspectors are looking for
Preparing for and managing inspections successfully
Conducting a mock inspection
The latest inspection trends
Real-world examples from global inspections will help you understand what inspectors expect in practice.
Programme
Background GMP audits and inspections play a fundamental role in quality management within the pharmaceutical industry. Pharmaceutical companies must conduct audits of their suppliers, while both companies and suppliers are regularly inspected by national and international regulatory authorities, including the FDA. The outcome of an inspection can significantly affect a company’s operations and commercial prospects. Comprehensive and effective preparation is therefore essential for successfully managing an inspection and achieving a positive outcome.
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
Technical Requirements We use Webex for our live online training courses. 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.
Fees (per delegate, plus VAT) ECA Members EUR 1,890 APIC Members EUR 1,990 Non-ECA Members EUR 2,090 EU GMP Inspectorates EUR 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference Language The official conference language will be English.
Testimonials
