Agenda:

Day One

Day 1 Schedule

FDA Regulations and Requirements Overview

• FDA 21 CFR Part 211 and 21 CFR Part 11
• Most frequently cited FDA 483s and warning letters
• Requirements overview from sampling to archiving
• Quality system requirements, e.g., ICH Q10
• The concept and practice of risk based compliance

Planning for quality and cGMP compliance

• Developing and using a validation master plan
• Scope, objectives and key elements of the master plan
• Developing and using FDA compliant SOPs
• Using templates to generate inspection ready documentation
• Planning for efficiency cost-effectiveness

Calibration and Qualification of Laboratory Equipment

• FDA requirements
• USP chapter <1058> for instrument qualification
• Going through examples for qualification steps (DQ, IQ, OQ, PQ)
• SOPs and deliverables for three instrument categories
• Developing calibration and qualification protocols

Equipment Maintenance and Change control

• Preventive maintenance; tasks, documentation
• Planned and unplanned changes
• Changing hardware, firmware, documentation
• Definition and handling of like-for-like changes.
• Requalification: time and event based

Validation of Laboratory Computer Systems

• Going through a complete laboratory computer system validation from beginning to end
• Integration the GAMP® guide with USP <1058>
• Periodic evaluation to reduce revalidation efforts
• Revalidation: why, what, when
• Change control of computer systems

Validation of Analytical Methods and Procedures

• Implementing the new FDA method validation guide
• Parameters and tests according to ICH Q2
• Developing a validation plan, protocols and a report
• Setting acceptance criteria for different applications
• Verification of compendial methods according to USP <1226>
• Transfer of analytical procedures according to USP <1224>

Day Two

Sample Testing: Preparation, conduct, documentation

• Preparing the equipment
• Setting specifications and acceptance croteria
• Documentation of test results
• Review and approval
• Not to forget: Review of electronic audit trail

Handling out of specification(OOS) test results (*)

• Going through the FDA OOS guide
• Learning from recent FDA warning letters
• Going through an OOS checklist
• Using out of trend (OOT) data to avoid OOS results
• Documentation and follow-up: root cause, corrective action plan, preventive action plan

Quality assurance of reference standards and other supplies

• Supplier qualification vs. sample testing
• Selection and assessment of suppliers
• Retesting of materials
• Preparing working standards from reference standards
• Correct labeling of chemicals

Training for GMP compliance

• FDA and international requirements
• Identification of training needs
• Developing a training plan
• Making GMP training interesting
• Documenting effectiveness of training

Ensuring Integrity of Raw Data and Other records

• FDA Part 11 and EU-PIC/S Annex 11 requirements
• Recommendations from guidance documents
• Definition of Raw Data: Electronic vs. paper
• Acquisition and recording of raw data
• The importance of electronic audit trail
• Review of electronic audit trail
• Archiving of electronic records for 'ready retrieval'

Internal audits in preparation for FDA inspection

• Understanding FDA and PIC/S inspection guides
• Scheduling of audits
• FDA Inspections as model for laboratory audits
• Going through a typical FDA laboratory inspection
• Responding to typical inspectional/audit deviations
• How to avoid FDA 483s and warning letters