Overview: Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations.

Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.

For easy implementation, Attendees will receive the Labcompliance documents:

• Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
  
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• SOP: Archiving GLP Data and Other Documents

Overview: Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.

Companies are unsure on what exactly to qualify or re-qualify, test and document.  The  main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This has changed. The USP has developed a new standard for analytical instrument qualification (AIQ).

Reference material for easy implementation:

• SOP: Analytical Instrument Qualification for <1058>
  
• SOP: Allocating Analytical Instruments to USP <1058> categories
  
• SOP: Procedures and deliverables for USP <1058> categories

Areas Covered in the Session:

• FDA and EU analytical instrument requirements
  
• Most common inspection problems
  
• Terminology, scope and principles of US chapter <1058>.
  
• AIQ and its relation to method validation, system suitability testing and quality control checks
  
• Essential steps for AIQ: DQ, IQ, OQ, PQ
  
• Purpose and contents of design qualification, installation qualification, operational qualification, performance qualification
  
• Allocation of instruments to the three categories A, B and C
  
• Procedures and validation deliverables for the three categories
  
• Recommendations for firmware and software validation
  
• Roles and responsibilities: QA, manufacturer, user
  
• Approach for automated systems (incl. firmware/computer systems)
  
• Qualification of existing systems
  
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  
• Recommendations for effective implementation

Who Will Benefit:

• Laboratory Managers and Staff
  
• Analysts
  
• QA Managers and Personnel
  
• Regulatory Affairs
  
• Training Departments
  
• Documentation Department
  
• Consultants
  
• Validation Specialists
  
• Regulatory Affairs
  
• Training Departments
  
• Documentation Department
  
• Consultants

Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

So far there have not been official guidance on what exactly is expected to maintain 'the validated state'. Now the USP is preparing for a general chapter and the FDA has released an official guidance on how to conduct and document method transfer. The guide has been developed for medicated feed assays but the principles can be applied to other methods. Now it is a good time to learn how to conduct and document method transfer for FDA compliance.