You will learn how to prepare for and what is the appropriate conduct during Inspections. Acquire the suitable skills necessary for responding to inspector’s questions. Descriptions of what records you have to provide and what records you should not provide. Learn how to write a procedure for preparing for FDA and other regulatory agency inspections.
The importance of data integrity and control of electronic records, with particular regards for recent problems with Indian API manufacturers. A comprehensive review of having and following written laboratory investigation procedures. Providing and maintaining adequate audit trails for traceability to your original data.
The seminar will be interactive, to allow delegates to discuss examples from their own inspection experience, and will also include practical exercises in making presentations to inspectors and compiling inspection responses.
- Gain understanding of the legislation behind regulatory inspections and the different types of inspection
- Understand the requirements for an effective Quality Management System
- Gain understanding of what inspectors are looking for during an inspection
- Learn how to prepare for a scheduled inspection
- Understand what to look for in a pre-audit self-inspection
- Identify pitfalls and errors during an inspection
- Understand what to say, how to say it, what you should NOT say
- Learn how to respond to deficiencies during an inspection and the follow-up CAPA
DAY 1 :
Regulatory & legal basis for GMP & GDP Inspections
- Development of global and EU rules and regulations
- EU & FDA GMP requirements
- Types of inspection & competent authority expectations
- Examples of recent regulatory inspection findings
Quality Management Systems
- Characteristics of a successful QMS
- Overview of ICH Q10 (Quality Management Systems) and Q9 (Quality Risk Management) guidelines
- FDA ‘Six Systems’ Approach to Quality Management
- Data integrity
- Handling changes & deviations
- Quality by Design
- Senior management responsibilities in a compliant QMS
Preparation for an Inspection
- How to write an SOP for Inspections
- Pre-inspection internal audit
- Preparing the site and meeting room
- Assembling documentation
- Site Master File
- Quality Manual
- Product Quality Reviews
- Effective SOP’s
- Training records
- Allotting audit team roles and responsibilities
- Contacting the inspector
Delegates will be provided with details of pharmaceutical manufacturing and distribution sites which have been notified about a forthcoming regulatory authority inspection. You will formulate an action plan to make the facility ‘inspection ready’ and ensure relevant staff and documentation will be available for the inspector.
DAY 2 :
Regulatory Authority Inspections
- Inspection team
- Receiving the inspector – first impressions count!
- Opening presentation
- Facility tour
- Answering inspector’s questions
- Managing the audit room
- Document review
- Inspection do’s and don’ts
- Closing meeting
- EU post-inspection letter
- Critical, Major & Other deficiencies
- FDA 483’s
- Formulating the response
Further Regulatory Actions
- EU Compliance Management process
- FDA Warning Letter
Delegates will be presented with a series of findings from a regulatory authority inspection. You will look at the findings and work out priorities, devise root cause analyses and provide detailed corrective actions.
Managing Director, Somerset House Consultants
Robert Haslam is a pharmaceutical industry VP with over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice.
He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.
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Hilton Zurich Airport
Zurich, Switzerland | September 27 – 28, 2018