| Course Instructor: |
Destin A. LeBlanc |
| Course length: |
Two full days |
| Summary: |
This course is designed to comprehensively cover
basic issues in cleaning processes for pharmaceutical manufacturing
equipment and the validation of those cleaning processes. It begins
with cleaning objectives, moves into the design of cleaning
processes, and then covers basic cleaning validation issues. |
| 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: |
Cleaning Objectives |
| Section 2: |
Overview of Validation Programs |
| Section 3: |
Regulatory Issues |
| Section 4: |
Cleaning Technologies |
| Section 5: |
Engineering Issues |
| Section 6: |
Cleaning SOPs |
| Section 7: |
Residues and Limits
|
| Section 8: |
Analysis and Sampling |
| Section 9: |
Microbial Control Issues |
| Section 10: |
Validation Protocols |
| Section 11: |
Validation Strategies |
| Section 12: |
Validation Maintenance Customization: Subjects can
be expanded, shortened, and/or appropriately modified to fit your
training objectives. |
| 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. |