Consulting / Large Compliance Project Management
Quality & Compliance Services Inc. can help your company deal successfully with many specialized tasks, from the design of a complete Quality System through to assistance with all facets of ISO registration. Services include:
Gap analysis (see Audits, below)
Project management of large cGMP-related studies
Quality assurance projects
cGMP implementation for clinical trial products.
Call on us when you require expert guidance and proven effectiveness.
Audits
Gap Analysis
Quality & Compliance Services Inc. can pinpoint problems and their solutions, ensuring that your facility or operation meets cGMP/ISO requirements.
We will conduct a gap analysis on your Quality Systems. Then we will develop and deliver a prioritized compliance action plan based on this analysis, specifying how to prepare for your impending audit successfully.
Self-Inspections
We can perform full self-inspection activities as required by the U.S. cGMP.
Third Party Supplier Audits
Quality & Compliance Services Inc. provides third party supplier/subcontractor audits of:
manufacturers
packagers
labelers
distributors
warehouses
laboratories
components suppliers
drug product, containers and closures suppliers.
All audit findings are presented in a detailed audit report, prepared in our own format or conformed to yours.
Technical Writing Services
Meet cGMP/ISO documentation requirements and deadlines in a cost-effective manner, with reduced disruption of day-to-day operations.
Quality & Compliance Services Inc. technical writing services ensure:
Finished Standard Operating Procedures (SOPs) and related documents are clear, accurate and easy to use.
All documents are written in company's preferred style/format.
Work is completed quickly; our studies show that your staff saves (on average) 80% of the time it would take for them to generate the technical document themselves.
Work is performed with minimal intrusion: most work is done off-site; office space, computers, support staff, are not required from client.
You avoid hiring new permanent or contract employees.
Your existing staff stays focused on regular business.
Impact on your bottom line is minimized.
cGMP Training
Bring your company into compliance with cGMP requirements, and profit from a better trained, more efficient and effective workforce. Quality & Compliance Services Inc. designs, develops, and delivers targeted cGMP training to audiences ranging from line operator to management.
We will develop customized courses to meet your unique requirements, or deliver our full-day overview course "Fundamentals of cGMP," which includes instruction on the following:
Understand the concepts of cGMP regulations.
Understand the importance of cGMP compliance.
Understand the Manufacturing Cycle.
Apply cGMP regulations to the Manufacturing Cycle.
Develop a personal Action Plan to ensure compliance at your company.
Benefits of this course include the following:
Obtain a basic understanding of cGMP regulations and how they apply to the Manufacturing Cycle.
Apply cGMP regulations to ensure compliance levels are met.
Meet government training requirements.
Our courses feature interactive exercises, case studies, and hands-on tasks designed to involve and engage the participant. Courses can be customized to incorporate company-specific examples and documents. You can also choose to have us develop a curriculum based on a needs analysis of your organization.
Your staff will benefit from our facilitators' broad-based experience in quality control and quality assurance, cGMP, ISO 9000, and technical documentation. Q&C can provide on-site delivery, working closely with you to reduce scheduling conflicts. We can also help you put in place a system for training effectiveness evaluation, as required by cGMP guidelines.
Regulatory Services
Canadian DIN submissions
Common Technical Documents (CTD) preparation
Post-Marketed Drug Services, i.e. changes to marketed products
cGMP Booklets
Quality & Compliance sells an indexed, pocket-sized version of the U.S. cGMP. An electronic order form is available
here.
ISO Services
Implementation
New system implementation
Upgrade to ISO 9001:2000
Gaps audits
Technical writing of policies, procedures, work instructions, and records.
Training
QSR Overview (1 day)
QSR Essentials (2 days)
QSR Comprehensive (3 days).
ISO Support Services
Ongoing quality system services (e.g., monthly maintenance)
Internal audits.