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Regulatory Compliance Consulting Services
Today’s pharmaceutical and medical device industry executives are
challenged with creating strong, compliance-centric cultures within an
ever-expanding complex global organizational structure. More and more
industry managers and executives see the wisdom in Aristotle’s quote
‘We are what we repeatedly do” as they implement their organizations
compliance programs. These executives recognize “Compliance”,
differentiated from “Quality”, as a critical competency for
maintaining their company’s competitive position, and more importantly
as a key factor for assuring the highest quality in their manufactured
products.
The FDA-regulated industry must comply with strict regulations (i.e.,
GMP’s; Quality System Regulation) to meet current FDA expectations.
Failure of pharmaceutical manufacturers to comply with current GMP’s
and the FDA’s expectations may result in a variety of negative
business-related impacts. These impacts include: withheld distribution
of product, lost revenue, falling stock prices, delayed product
approvals, fines, cancellation of government contracts, product
recalls, litigation, consent decrees, warning letters, and, worst of
all, adverse affects or physical harm to consumers.
The mission of our Compliance Consulting Group is to eliminate the
risk of FDA enforcement in our clients’ operations. The demand for our
compliance consulting services to assist our clients mitigate the risk
of non-compliance has been increasing due to a growing number of
pro-active executives making “Compliance” an integral part of their
operational plan and journey towards operational excellence.
To help our clients achieve a higher level of compliance, we provide a
number of services including:
• FDA / GMP Compliance Reviews
• FDA Inspection Planning
• Non-Compliance Remediation / Project Management
• Quality System Policy and Procedure Development
• QSIT Audits
• Quality System / GMP Audits
• Quality System Policy Assessments
• Quality System Review and Design Services
• GMP Training
• Validation Audits
• Validation Program Assessment
• Validation Master Planning
The FDA is currently in the process of revising the GMP regulations to
be more comprehensive, clear and consistent to minimize interpretive
differences between the agency and industry. The FDA has implemented a
more systematic approach to inspection of a firm’s compliance to
current GMPs called the Quality System Inspection Technique (QSIT).
The QSIT helps the resource-constrained FDA streamline its inspection
process by focusing on critical “Quality System” areas.
The FDA’s focus on production-centric quality management systems /
policies, such as, CAPA, Process Change Control, Management Controls,
Design Controls, etc. makes it easier for the FDA to identify
core-weaknesses in a company’s practices. Any one of these areas found
non-compliant with FDA expectations would be sufficient evidence for
the FDA to judge the company as having significant systemic problems
that may result in regulatory action. Using the QSIT as a guideline,
Compliance Team has developed an audit tool tailored to assess
compliance to ISO 13485, CFR 211, and CFR 820 regulatory requirements
that quickly uncovers compliance gaps and helps to identify areas of
compliance-risk and to set priorities for remediation efforts. Contact
us for more information on this audit tool.
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