SERVICE OFFERINGS

    Training, Teambuilding and Development Services










    Training is an integral component to achieving total compliance.  Through a
    partnered approach in preparing your organization to comply with regulatory
    and quality requirements, we can customize our training programs to meet the
    needs of your organization.  Our courses, seminars and workshops are
    conducted by instructors with decades of professional expertise in the pharma-
    ceutical and biotech industries.  They are excellent presenters and serve as
    subject matter experts in their fields.  The training courses we offer can help
    satisfy the requirements for some of the following agencies and guidelines:

  • U.S. Food and Drug Administration (FDA)
  • U.S. Environmental Protection Agency (EPA)
  • International Organization for Standardization (ISO)
  • World Health Organization (WHO)
  • International Conference on Harmonization (ICH)
  • Canadian and Australian GMPs

    In addition to the standardized courses we offer, VQI can develop customized
    training to meet your organization's requirements for either on-site or off-site
    venues.


    Technology Solutions for Research and Development





    Our professionals are dedicated to serving customers by developing and
    augmenting the technology and validation needs of your organization.  VQI
    provides comprehensive consulting and technology solutions that utilize an
    extended knowledge base, along with regulatory insight in achieving
    compliance in your organization.  To assist you in meeting global regulatory
    and quality standards, we offer a boutique of services covering the areas of
    cGMP, GLP, Analytical Microbiology, Cleaning Validation, Aseptic Validation
    and Synthesis.

    VQI can also assist in the development of procedures and documentation to
    ensure compliance with quality and regulatory requirements in the areas of
    cGMP, GLP and ISO 17025.  Through a meticulous scrutiny policy, we can
    ensure that your methods are updated and comply with current guidelines.


    Auditing and Assessment Services








    Our auditing and assessment services can uncover potential issues before they
    result in noncompliance findings within your organization.  VQI conducts audits
    in several areas including:

  • Current Good Manufacturing Practices (cGMP)
  • ISO-17025
  • Good Laboratory Practices (GLP)
  • World Health Organization (WHO)
  • ISO 9000 / ISO 2000
  • Laboratory Internal Audits
  • Australian and Canadian GMP
  • Vigilancia Sanitaria (Brazil)


    Validation Services

    Our team of experts can provide solutions in several areas of pharmaceutical
    and biotech validation.  We have the ultimate resources available to resolve
    validation issues at all levels.  These resources can assist in developing a
    comprehensive approach for targeting compliance in validation:

  • Analytical and Microbiology Validation
  • Software Validation
  • Instrument Validation (IQ, OQ, PQ)
  • Computer Validation
  • Water Quality Validation
  • Cleaning Validation
  • Process Validation
  • WFI
  • Various Regulatory Issues
  • Design Validation

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c-GMP
ISO-17025
GLP (FDA, EPA, OECD)
OECD Guidelines
ISO 9000 / ISO 2000
Australian GMPs
IAR and NATA
Canadian GMPs
ISO Auditing
Regulatory Submission of IND, NDA and ANDA
GAP Auditing
Cleaning Validation
Synthesis and Discovery
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All Rights Reserved





























Contact Us

                               

Dr. Shib Mookherjea
ValQual International
3959 Pemberly Pines Circle
Saint Cloud, FL  34769

or

ValQual International
P.O. Box 170
Florham Park, NJ  07932

Phone: 201-615-6346
Fax: 407-498-2027

email:
info@valqualintl.com

Administrative Manager
Wendi Petrone
Fax: 864-963-7899
email:
wpetrone@valqualintl.com