FDA Compliance, Quality, and Regulatory Solutions
FDA Compliance Assessment – A complete risk assessment and gap analysis to ensure compliance
to applicable standards. Our third party auditors provide expert auditing services for both domestic and
international firms. We understand the regulations and are able to identify gaps and determine an
accurate risk analysis. We provide an expert or team to evaluate your firm’s current systems and
provide executive management audit reports which highlight both risk and recommended corrective
actions.
On-Site Training – Training facilitators provide on-site customized personnel and management training. The interactive training sessions focus on understanding current industry standards and practices. Our instructors provide numerous real examples to strengthen the training experience.
Quality System Implementation – Based on the initial regulatory gap analysis and the regulations
our quality system experts can implement a new system that fits your organization or improve your firm’s existing quality system. This includes a validation process for SOPs, Policies, Checklists, and Protocols.
Vendor Auditing – A complete compliance audit to ensure your firm’s vendors are delivering quality
products in compliance with the regulatory standards.
Benefits
Improved Safety
Reduced Cost
Improved Regulatory Compliance
Reduced Risk
Methods
Interactive Strategy Maps, Facilitated Experiential Workshops, E-Meetings & Pro-active Coaching
Pricing – Competitive costs structure; discount packages available; varies based on program.
phone 866-362-9800
email info@q4medsource.com
web www.q4medsource.com.
Q4 can help you achieve it all. The tools to help grow your business. The people to help guide you.
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