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Destin
A. LeBlanc
Cleaning
Validation Technologies
Technical
Consulting Services |
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Training for Professional Staff |
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Cleaning Validation Technologies offers the
following two on-site training sessions for professional scientists and
managers involved in cleaning and cleaning validation.
The difference between the two training modules is that the first includes
training on both the design of cleaning processes and cleaning
validation, while the second focuses exclusively on the validation aspects
of cleaning processes. |
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| Title: |
Basic Concepts in Cleaning and Cleaning
Validation |
| 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. |
|
|
| Title: |
Good
Cleaning Validation Practices |
| 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 |
|
| 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. |
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For
further information, contact Destin LeBlanc at
email.
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