The programme covers all aspects of GMP including the recent developments within the regulatory environment in Europe. The implications of the additional EU regulatory requirements are going to be discussed and the course leader provided practical suggestions as to how to implement these requirements. Delegates will also have the opportunity to work through problems with other delegates and to exchange experiences, whilst supported by the course leader.
This two day course will be combination of presentations and workshop allowing full participation of the delegates and is aimed at QA Managers, Production Managers, Regulatory Compliance Managers, Warehouse Managers, and Academicians.
Course Leader: Dr. Afshin Hosseiny
PROGRAMME
18 September 2007 / Day I
08.30 Registration and Welcome Coffee
09:00 Welcome and Opening of the Seminar
09:30 Introduction
• History and legal status of GMP
• Product licences and manufacturing licences
• The EU Guide to GMP
• The USA Code of Federal Regulations (CFR)
• Regulatory authorities in Europe
10:30 EU GMP requirements
• Role of Quality Assurance and Quality Control units in maintaining GMP standards
• Role and responsibilities of Production management
• New GMP requirements for APIs (ICH Q7a & EU GMP Annex 18)
• New GMP/ICH requirements on Development and Investigational Medicinal products (ICH Q8, and EU GMP Annex 13)
• Quality Risk Management (ICH Q9)
• The role of Qualified Person in EU (EU GMP Annex 16)
11:30 Tea/Coffee
12:00 Annual product quality review (workshop)
• Regulatory requirements
• Scope of the EU directive
• Roles and responsibilities of the licence holder
13:00 Lunch
14:30 GMP Documentation (workshop)
• How to develop GMP documents
• Maintaining of documentation
• Document change control
• Training requirements
• Best practices for GMP documentation
15:30 Tea/Coffee
16:00 Standard Operating Procedures (SOPs)
• What is an SOP
• Regulatory requirements
• Identifying the need for SOP
• How to develop and write SOPs (best practices)
• SOP maintenance
17:00 Q&A and close of day 1
19 September 2007 / Day I
9:00 Qualified Person
• Role and responsibilities of a QP
• Routine duties of a QP
• How to become a QP - QP training
• QP in the organisation
• Continuous Professional Development for QP
9:45 Batch documentation
• Batch record (best practices)
• Batch record review and batch release
• Regulatory requirements
• Non-batch- related data (e.g. water testing data)
• Final check of the packs before release
10:15 Product security
• Line clearance
• Sampling
• Stability programme
• Change control
11:00 Tea/Coffee
11:30 Failure investigation and corrective action planning
• Deviation handling
• Failure investigation
• Corrective action and preventive action planning (CAPA)
• Documentation of failures and CAPAs
• Data trends and review
12:30 Lunch
14:00 Complaints (workshop)
• Handling complaints
• Investigating Complaints
• Collecting and analysis of trend data
• Utilising trends in process improvement
15:00 Tea/Coffee
15:30 Developing a GMP culture
• How to develop training and education programme
• How to maintain GMP compliance status
• GMP training updates
16:30 Final Q&A
17:00 Close of Course
COURSE LEADER
Dr. Afshin Hosseiny
Bsc. Msc. Ph. D. C. Chem MRSC M.inst. Pkg
• QA director for GlaxoSmithKline until April 2004
• QP via permanent provisions
• Has worked with manufacturers (primary and secondary, sterile and non-sterile), wholesalers and distribution centers across Western Europe, the Far East and the USA
• Detailed working knowledge of European and FDA validation requirements
• More than 15 years experience of preparation for and fronting of regulatory inspections.
Afshin has hands on experience on design and validation of filling and packing lines for products supplied to SA, he is a member of the UK standards committee for development of the ISO GMP standards for packaging components.
