Course Instructor: Destin A. LeBlanc
Course Length: Two full days
Summary: This course is designed to comprehensively cover the validation of equipment cleaning in pharmaceutical manufacturing. It covers in more depth setting limits, analytical methods, sampling, protocols, strategies, and validation maintenance.
Target Audience: This training is designed for professionals engaged in the design, execution, and validation of cleaning processes. This includes validation scientists, analytical chemists, microbiologists, QA/QC scientists, production engineers, toxicologists, regulatory specialists, and their managers.
Format: This training primarily is in lecture format, but includes two small group exercises. Interaction and questions are encouraged to faciliate understanding.
Course Outline: Section 1: Introduction and History
Section 2: Residue Limits
Section 3: Analytical Methods
Section 4: Sampling Methods
Section 5: Protocols
Section 6: Cleaning Validation Strategies
Section 7: Cleaning Validation Maintenance
Section 8: Regulatory Guidance
Fees: The fee for standard two-day course is $10,000 plus travel expenses. If the course is shortened to a one-day presentation, the fee is $7,500 plus travel expenses. In either case, the client provides the training facility with a video projector and a writing board/flip chart. This fee includes all training material and certificates of completion. Cleaning Validation Technologies will send the client a pdf file of the training materials for photocopying and assembling into training booketls by the client.