Sanbec Consulting has standard modules available on the following topics. In house and bespoke training is a speciality and can be arranged to suit your requirements:
· ICH Q7, Q8. Q9, Q10 (up to 2 days; Q8, 9 and 10 are combined)
· What do these standards mean to you, how can you apply them and audit against them
· Technical Transfer (2 days)
· Technical/Quality Agreements (1 day)
· Auditing Techniques (2 days)
· What makes a good auditor? How do you audit? Many practical workshops are included in this training
· ISO 9000 (system overview) (1 day)
· EXCiPACT auditor training (2 days)
· Bespoke GMP and QA (up to 2 days)
· FDA Inspections (2 days)
· How to audit API plants (2 days)
· Auditors with drug product backgrounds often find auditing API suppliers bewildering, so what are the key aspects they should be looking for?
· Regulatory agency inspection preparation (2 days)
· Success in Regulatory inspections starts many weeks before the inspection and continues until well after the inspection has closed. What are the key steps to ensuring that your sites are prepared?
· Excipient requirements and latest approach to compliance (1 day)
· Impact of FDA GDUFA to API and Excipient manufacturers (Generic Drug User Fee Act) and how to prepare (2 days)
· Cleaning validation (1 day)
· Your equipment appears clean, but can you prove it? How to do comprehensive cleaning validation with minimum effort?
· Good documentation practice (1 day)
· Good distribution practice (1 day)
· PS 9000 (a standard for suppliers of packaging to the Pharma industry) (1 day)
· Key aspects of a Quality System (with the perspective of what the regulators are looking for) (1 day) e.g. Change Control, Out of Specification, Self Inspection
· ICH Q7, Q8. Q9, Q10 (up to 2 days; Q8, 9 and 10 are combined)
· What do these standards mean to you, how can you apply them and audit against them
· Technical Transfer (2 days)
· Technical/Quality Agreements (1 day)
· Auditing Techniques (2 days)
· What makes a good auditor? How do you audit? Many practical workshops are included in this training
· ISO 9000 (system overview) (1 day)
· EXCiPACT auditor training (2 days)
· Bespoke GMP and QA (up to 2 days)
· FDA Inspections (2 days)
· How to audit API plants (2 days)
· Auditors with drug product backgrounds often find auditing API suppliers bewildering, so what are the key aspects they should be looking for?
· Regulatory agency inspection preparation (2 days)
· Success in Regulatory inspections starts many weeks before the inspection and continues until well after the inspection has closed. What are the key steps to ensuring that your sites are prepared?
· Excipient requirements and latest approach to compliance (1 day)
· Impact of FDA GDUFA to API and Excipient manufacturers (Generic Drug User Fee Act) and how to prepare (2 days)
· Cleaning validation (1 day)
· Your equipment appears clean, but can you prove it? How to do comprehensive cleaning validation with minimum effort?
· Good documentation practice (1 day)
· Good distribution practice (1 day)
· PS 9000 (a standard for suppliers of packaging to the Pharma industry) (1 day)
· Key aspects of a Quality System (with the perspective of what the regulators are looking for) (1 day) e.g. Change Control, Out of Specification, Self Inspection