Course Agenda
Day One (8:30 AM - 3:30 PM)

8:00 – 8:30 AM: Registration

8:30 – 10:00AM: Session 1: Good Manufacturing Practices: Core Concepts
  • Core principles of GMP
  • Regulatory requirements for different kinds of drugs: chemical, biological, combination and mixtures
  • Customizing regulatory compliance to a given product
  • Role of discussions with the FDA

10:00 – 10:15AM: Break

10:15 – 12:00 noon: Session 2: Quality Management Systems for Manufacturing
  • Essential elements of the Quality systems
  • Creation and logistic of the QA Unit
  • Documentation requirements
  • Training and supervision practices
  • Audit plans and procedures

12:00 – 12:45PM: Lunch

12:45 – 2:15PM: Session 3: Material Management
  • Raw material, intermediates and finished product handling
  • Vendor management
  • Certificates of analysis and QC testing of incoming and outgoing materials

2:15 – 2:30AM: Break

2:30 – 3:30PM: Session 4: Process Validation and Change Control
  • Process validation basics
  • Current FDA and ICH regulations and guidance for PV
  • Step-by-step instructions for PV reports and documentations
  • Evaluating Change Control requirements
  • Best practices for Change Control in GMP systems
Day Two (8:30 AM - 3:30 PM)

8:30 – 10:00AM: Session 5: CAPA
  • Requirements of the CAPA process and procedure
  • Essential elements of the CAPA file and their intended purpose
  • CAPA documentation processes including CAPA plan, SOPs, and written policies
  • Best practices for CAPA process
  • Management oversight and monitoring CAPA activities
  • Deviation management and non-conformance analysis

10:00 – 10:15AM: Break

10:15 – 12:00 noon: Session 6: SOPs and Documentation Practices 
  • Essential elements of an SOP
  • Role of personnel in creating SOPs
  •  SOP revisions, updates, creation, retirement and documentation
  • Training practices for FDA compliance
  • Targeted and derived documentations requirements
  • Master records, Batch records, QC testing records, QA reports, and other documents

 12:00 – 12:45PM: Lunch

12:45 – 2:15PM: Session 7: Facilities and Equipments
  • Facility design requirements
  • Access control and security
  • Equipment installation, validation, maintenance and updating
  • Computerized systems and Part 11 compliance
  • Disaster recovery and business continuity plans 

2:15 – 2:30AM: Break

2:30 – 3:30PM: Session 8: Current Trends in FDA’s GMP Requirements
  • FDA guidance process for GMP issues
  • GMP for Combination products
  • Processes to seek FDA’s advise  on manufacturing issues
  • Drug Master Files and cross-reference authorization process   
  • Facility registration requirements, fees, and documentation submissions
  • Trends in FDA’s auditing practices
  • Navigating the FDA’s web-site to find resources, tips and consultations
For additional information on the workshop agenda and logistics, please call 301-760-4952 or email: [email protected]