| Additional Info Here |
Services We Provide:
Auditing:
We offer auditing by a highly experienced
auditor with over 30 years of experience in
auditing against GMP and other quality
standards. We will provide quality audits of
your operations or those of your suppliers or
clients. We are particularly experienced in
quality audits and audits of quality control
and testing facilities.
Training:
We offer training in GLP and GMP regulations
and their requirements in the manufacturing
environment. We also provide training in
basic QC laboratory operations and simple
statistics for the laboratory.
Improvment:
We provide consulting services for
companies seeking to improve their GMP or
GLP compliance in manufacturing and
laboratory operations. Working in a continual
improvement atmosphere is fine with us,
especially in a program for Total Quality
Management.
Monitoring:
As a follow-up to auditing, training, or
improvement activities we will provide
GMP/GLP monitoring services to verify
Corrective and Preventive Actions, Process
Improvements, and the Effects of training.
Auditing:
We offer auditing by a highly experienced
auditor with over 30 years of experience in
auditing against GMP and other quality
standards. We will provide quality audits of
your operations or those of your suppliers or
clients. We are particularly experienced in
quality audits and audits of quality control
and testing facilities.
Training:
We offer training in GLP and GMP regulations
and their requirements in the manufacturing
environment. We also provide training in
basic QC laboratory operations and simple
statistics for the laboratory.
Improvment:
We provide consulting services for
companies seeking to improve their GMP or
GLP compliance in manufacturing and
laboratory operations. Working in a continual
improvement atmosphere is fine with us,
especially in a program for Total Quality
Management.
Monitoring:
As a follow-up to auditing, training, or
improvement activities we will provide
GMP/GLP monitoring services to verify
Corrective and Preventive Actions, Process
Improvements, and the Effects of training.
In recent years Steve has
been asked to audit
companies to determine
their state of GMP
compliance to find
weaknesses before
inspections or audits by
other organizations. He
has become experienced
at working with APIs,
drugs, and biologics
producers as well as
contract testing
laboratories.
After the audits,
confidential reports are
provided to company
management who then
decide on how and when
they will act to make
improvements.
been asked to audit
companies to determine
their state of GMP
compliance to find
weaknesses before
inspections or audits by
other organizations. He
has become experienced
at working with APIs,
drugs, and biologics
producers as well as
contract testing
laboratories.
After the audits,
confidential reports are
provided to company
management who then
decide on how and when
they will act to make
improvements.
GXP BioTechnology: Services
| TRAINING |
| Preparing for Inspections and Audits |
Classes are available for
the following:
GLP (21CFR58), GMP
(21CFR210,211,600&610),
Out-of-Specification Test
Results, Setting
Specifications, Assay
Validation, QC Laboratory
Statistics, & General Quality
Control Operations.
the following:
GLP (21CFR58), GMP
(21CFR210,211,600&610),
Out-of-Specification Test
Results, Setting
Specifications, Assay
Validation, QC Laboratory
Statistics, & General Quality
Control Operations.
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