PTI - international

Agenda: Day One

I. Overview of FDA Requirements and Trends

• Examine 21 CFR 210-211
• Highlight laboratory-related cGMP requirements (e.g., OOS, equipment calibration, etc.)
• Outline current FDA trends, including systems-based inspections and the FDA's risk-based
  initiative
• Review common citations and identify FDA inspectors' trigger points

Discussion: Compare Participants' Levels of Experience and Objectives for this Course

II. Personnel Qualifications and Training

• Interpret FDA requirements for personnel qualifications and training (21 CFR 211.25)
• Establish a training master plan for laboratory personnel
• Implement best practices for GMP training
• Maximize effectiveness of various modes of training, including on-the-job training
• Ensure personnel truly learn the material (hint: learning consists of three stages – acquiring information, interpreting it and applying it)

Exercise: Analyze an Example of a Citation Related to Personnel Qualifications

III. Standard Operating Procedures (SOPs)

• Identify laboratory-related SOPs required by FDA
• Outline contents of an SOP
• Apply principles of technical writing to SOPs
• Establish an effective process for SOP development and maintenance, including change control
  

Exercise: Identify the Main Components of an SOP for Analyst Training

IV. Blend Uniformity Testing

• Examine blend uniformity requirements and the FDA's current thinking
• Compare and contrast various sampling techniques
• Utilize a justifiable sample size
• Highlight common reasons for OOS results
  

Exercise: Analyze a Case Study of a Blend Failure and Identify Course of Action

V. Stability Testing

• Design and implement an effective stability program (hint: consistency is critical)
• Interpret current stability guidance documents, including U.S., EU and ICH
• Outline the stability process, from study activation through annual report
• Identify and avoid common stability-related deficiencies

Exercise: Write a Stability Protocol for a Hypothetical Product

VI. Chromatography and Dissolution 

• Review fundamentals and various types of chromatography
• Examine principles of high-pressure liquid chromatography (HPLC)
• Maintain and calibrate chromatography equipment and instruments
• Implement proper dissolution testing (USP <711> and <724>)

Exercise: Analyze a Dissolution Case Study
Exercise: Analyze a Blend Analysis Case Study