VTIs
Comprehensive Suite of Quality Assurance and Regulatory Affairs
Services includes:
- Quality System Development
- Policy/Procedure (SOP) Review and Development
- Agency Submission Review
- Regulatory Inspection Support
- FDA 483 Response Support
- Change Control Program Development
- CAPA Development / Support
- Vendor/Supplier Qualification and Audits
- Contract Manufacturer Audits
- Validation
- Documentation Review
- GMP, GLP, GCP, QSR, and Part 11 Compliance Audits
- Mock FDA Inspection
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Guidance
and Solutionsk:
You Can Trust VTI has assembled a team of Quality and
Regulatory Consultants with the expertise, skills, and
insight to make recommendations and create solutions you
can trust. Our Quality and Regulatory Consultants have
years of individual and collective experience within FDA
regulated industries that they bring to your project.
Our Consultants have worked with many of the leading companies
within the healthcare industry and have hands-on experience
with the best practices within the industry. |
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In addition, we regularly participate in industry associations
such as RAPS, ISPE and ASQ.
This allows us to have an ongoing dialogue with the leading
regulatory and industry experts and keeps us abreast of developments
that might affect your
company.
Quality Systems that Work:
Developing and improving quality systems is a mission-critical
goal. We at VTI, an ISO 9001 registered company, recognize the
importance of such systems and are
ready to help you implement simple and effective solutions that
address your
change control, product release, corrective action, and complaint
handling
requirements.
Our Quality
Systems services include:
- Quality Systems Assessments:
A thorough review of your existing quality systems using our
established auditing and assessment procedures will help to
identify the strengths, issues, and opportunities for improvement
within your quality program.
- Quality System Design and Implementation:
VTI Consultants have the hands-on expertise to produce customized,
simple and effective programs to implement their recommendations
and meet your needs. They also have the project management
skills and the ability to work with all levels of your organization
to implement a comprehensive quality system.
Auditors Who Understand Your Business:
Auditing is an invaluable tool for ensuring compliance with
regulations, guidelines, internal standards, and industry expectations.
VTI has developed a team of qualified auditors who have the
requisite skills and experience to uncover useful and relevant
information. Our auditors, many of whom have completed the ASQ
Certified Quality Auditor program, are experts within the industry
who understand your business, the regulations and the product
development and manufacturing environment. VTI will produce
a detailed comprehensive report that will identify potential
problems and weaknesses and identify effective solutions to
reduce the regulatory compliance risk.
VTI
Consultants can provide the following audits and regulatory
services:
- Mock Pre-Approval Inspection (PAI) audits
- Compliance Audits: Evaluate the compliance of your systems
and controls with cGMP/QSR regulations and implement corrective
actions prior to regulatory inspections.
- Third Party Inspections: The VTI team has performed hundreds
of audits of suppliers who sell a wide range of materials
and services. VTI can act as a representative of your Quality
group to perform internal and external Vendor/Supplier audits
and allow you to focus on your business while ensuring the
quality of your product.
Training for Success:
VTI can provide your company with practical, in-depth training
from industry experts who are up-to-date on emerging trends.
We will work with your company to tailor training to meet
your needs and to provide information that your employees
will use on a daily basis. By presenting training at your
facility we can reduce overall costs while your employees
remain accessible.
Our core training includes the following
topics:
- Regulatory Inspections
- GMP/QSR Training
- Failure Investigations
- Risk Management
- Validation
- Computerized Systems Validation
Our Promise to You:
The entire VTI team takes pride in our expertise and responsiveness
to your needs. Here are some of the qualities you’ll
find when you partner with VTI – qualities that ensure
your satisfaction.
- Expertise:
Your team will be staffed with industry experts who know your
business. They’ll be knowledgeable about the latest
regulations, directives, laws, policies, and guidelines that
are applicable to your products and market, and will be able
to sort through the details, interpret guidelines, and make
recommendations that are best suited to your organization.
- Integrity:
There is nothing more important to us than our reputation.
That’s why we’ll never make a promise we can’t
keep and we will make sure you understand the logic behind
every recommendation and action that we take.
- Quality Work:
When it comes to providing Quality Consulting services, we
are utterly uncompromising in our quest for perfection. We
are fanatical about paying attention to detail and accept
nothing less than the best from our staff.
- Cost-Effective Recommendations: We will
always recommend the most cost-effective solution and provide
you with honest and competitive quotes. And we’ll
also make sure that there is an option to meet your needs
and budget.
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