•
Strategic Planning: Our strategic planning process transforms
quality and business objectives into priorities that
enable regulatory compliance to be achieved across the
organization.
• Corrective Action Programs: By employing active
monitoring of FDA-483s, Warning Letters and other legal
sanctions, CTTI is able to translate observations into
terms that help maintain timely and orderly execution
of corrective and preventive actions.
• Regulatory Guidance: Our monitoring of industry
trends can tilt the scales of compliance in your favor
by keeping your organization current with ever-changing
regulations, while avoiding the financial drain that
can result from inefficient approaches to regulatory
compliance.
• Project Management: Through skillful planning,
scheduling and implementation, CTTI can expedite corrective
and preventive actions in a way that compresses time,
streamlines activities and maintains rigorous control
over project implementation.
• Product Development and Manufacturing: Our use
of risk assessment tools and techniques can enhance
your regulatory compliance profile, while offering more
options for optimizing your product development and
commercial manufacturing operations.
• Regulatory Liaison: CTTI is well known for professional
working relationships with regulatory authorities. Our
insight can help improve your credibility by identifying
what’s really important, and then communicating
reasonable objectives and timeframes for addressing
compliance concerns in a way that represents your best
interests.
From
change control, product release, validation and adverse
event reporting to corrective and preventive action,
quality control testing and complaint handling, our
professionals base their approach on a process that
serves the organization.
Our
services include:
•
Quality Systems Assessments: By employing defined methodologies
for quality systems assessments, CTTI is able to evaluate
your organization’s quality practices and identify
opportunities that will enable you to economically achieve,
sustain and improve quality in all aspects of manufacturing.
• Quality System Design: Our tools and templates
for the design of critical quality systems can improve
operational efficiency and reduce compliance risk by
linking employee behavior and responsibility to quality
systems in a language that everyone can understand.
• Policies and Procedures: Our flexible models
and templates for creating customized quality systems
can expedite the creation of quality policies and procedures
that are right for your organization.
•
Implementation Plans: From start to finish, our skillful
change management process can help assure successful
implementation of new quality programs by overcoming
cultural inertia that can derail your quality initiative.
•
Quality System Standards: Not only do we help design
a quality program, we also help create corporate-wide
quality standards that can be used across an organization
to judge operational efficiency, improve the sharing
of information and strengthen the organization’s
overall compliance posture.
Canadian
Technology Team Inc
123 White Blvd
Thornhill
ON - L4J 5Z1
Canada
Phone:
1-866-209-8842
Email: info@cantechteam.com
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