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The Validation Basic Workshop
has an approximately 25 hours of direct contact and a total of 4
to 6 hours of home work.
NOW with one extra full day of qualification execution in real pharmaceutical equipment!
Discussion Topics:
- Current Good Manufacturing Practice (cGMP's) cGMP's definitions,
history and impact in the Validation area focus in:
- Organization & Personnel
- Facilities
- Equipment
- Documentation
- Good Documentation Practice Basic principles and guidelines
for conducting a good documentation execution for compliance with
regulatory requirements.
- Validation Concepts Present an introduction of the components
of the term "Validation" follow up with the definitions of these
major concepts. Gave a taste of the history of validations based
in the targets and seasoned with the regulatory requirements.
Aspects covered:
- Validation Documentation
- Design Qualification (DQ)
- Commissioning
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Facilities, Equipments and Utilities
- Change Control and Re-Validation
- Standard Operating Procedures Present the essential part
of SOP's function and requirements related with validation
activities.
- Technical Writing for Validation Some topics to be covered
are:
- What is a Validation Protocol?
- Regulatory requirements of the Validation Protocol
- Validation Documents
- Protocol Contents
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- Protocol Development
- IQ Documentation
- Engineering/ DQ Documentation Construction Documentation
- OQ Documentation
- PQ Documentation
- Validation Master Plan Present definitions, contents, types
and functions of Validation Master Plan
- Equipment Qualification Delineate organized the most important
aspects of: DQ, IQ, OQ, PQ, Re-Qualification
- Process Validation Present the following topics:
- Product Attributes
- Process Parameters
- Process Control Parameters
- Technology Transfer
- Sampling
- Acceptance Criteria
- Introduction to Statistical & Process Qualification Studies
Computer and Control Systems Validations Some topics to be covered
are:
- FDA's Definition & Regulatory Requirement
- Verification Techniques
- Validation vs. Verification
- CSV System Life Cycle
- CSV Risk Assessment
- General Methodology and Documentation Development Techniques
- ONE FULL DAY Live Workshop examples and exercises
What you get is what you need:
(1) Learn the latest and most useful information from
active consultants in the Regulated Industry - you will learn the
do's and don't to be successful, even interview and resume tips.
(2) Small groups - Courses are easier to follow, you will get
the attention you need and your questions will be answered.
(3) Advanced Active Learning Methods - You will view professional
made PowerPointŪ presentations that include equipment, processes
diagrams and images.
(4) Experience group discussions and real industry validation applications
and situations.(5) We will provide with a cGMP's booklet,
Regulatory reference information & access to our reference documentation
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Validation Basic Workshop
ONLY $999
( Spaces are limited)
Saturday
Course (Three (3) days) From 8:30AM TO 6:00PM
Reservations
(click here to purchase): You can reserve
your space now (available 24 hours) in our Fully
Automated Electronic Reservation and Payment System (all mayor
Credit cards accepted).
Go
to our secured site to view dates available and to make your reservation
Open
On-line Fill-in printable Fax Form & Questionare
Download
Fax Request Form (The approval of this fax request will depend on
Course (s) availability) -
use this one if prior link does not work!
(Fax reservations will be confirmed by phone)
QUESTIONS?
contactus@pvsrwebsite.com
CALL US 787 807 PVSR (7877)
CALL US 787 807 PV00 (7800)
FAX US 787 807 FAX0 (3290)
About the Workshop Training
Leader
Partial Payment
Method!! PVSR
provides now a Payment Option which consists of the split
of the total cost of the workshop or workshops that you will take
over a three (3) month period. Please download the application form
and agreement and send it by fax to 787 807 FAX0 (3290) for
evaluation.
Payment Option Form (PDF)
Payment Option Form (Word)
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