Equipment Qualification

• FAT and SAT

• Equipment and process characterization

• IOQ / PQ

Validation / Re-Qualification

• Cleaning (CIP / COP)

• Steam Sterilization (SIP)

• Bulk Heat Sterilization (BHS)

Process Validation

• New Product / Technology Transfer

• Batch Size / Capacity Increase

• Product Filtration / Filter Validation

• Aseptic Process Simulations

Technical Writing

• Manufacturing Documents

• Standard Operating Procedures

• Gap analysis

• Process Flow Chart Design

• Drawing Review and Redlining

Quality Management Systems

• Change Control Management

• Non-Conformances Mitigation and Closure