1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
Bulletproof
Validation
of Methods, Equipment, Process, Utilities and Facility
About this course
As part of GMP compliance, regulatory authorities expect healthcare manufacturers to validate their production and control equipment, production process, analytical methods, facility and production utilities.
Inadequate validation still tops the list of objectionable observations of regulatory inspectors during prelicensing and GMP inspections.
This course teaches how to plan for validation and how to write and execute validation protocols that meet regulatory expectations.
Selection and appropriate supervision of outside validation contractors will also be discussed.
YOU WILL BENEFIT FROM THIS COURSE…
if your responsibility includes validation
if you belong to Quality Assurance or Quality Control
if you are responsible for GMP compliance or are auditing for GMP compliance
if you are involved in process development
if you are involved in project management
if you are an engineering contractor
if you are a validation contractor
if you are responsible for manufacturing
if you simply need a better understanding of state-of-the-art validation practices
THIS COURSE WILL IMPROVE YOUR KNOWLEDGE OF...
how to effectively plan for validation
how to validate production equipment
how to approach software and cleaning validation
how to validate the manufacturing process
how to validate analytical methods
how to ensure that validation was to the point and is comprehensive
how to cost-effectively validate while maximizing regulatory compliance
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