| 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 mangers. |
| Format: |
This training primarily is in a lecture format, but includes two small-group exercises. Interaction and questions are encouraged to facilitate 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 the standard two-day course is $8,500 plus travel expenses. If the course is shortened to a one-day presentation, the fee is $6,000 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 materials and certificates of completion. For training in the USA, Cleaning Validation Technologies will prepare the training booklets and ship them to the training site. For international locations, Cleaning Validation Technologies will send the client an original set of the training materials for photocopying and assembling into training booklets by the client. Fees for customization of the course usually are about $1,000-$1,500. |