Our Audit Services enable you to be proactive with regards to your quality assurance and regulatory compliance status.
· PAI Preparation Audits - don't find out too late what is wrong
· Vendor/Contract Mfg Audits - raw materials, components or services
· General Assessment - verify that you are in compliance with federal regulations
· GMP Gap Analysis - evaluate where you are and where you should be
· Full Audit Service - our 5-step approach is complete and efficient
· Due Diligence - evaluate your next acquisition before purchase
Is GMP a way of life at your company? Our Training Programs can provide a hands-on solution to your training needs:
· In-house GMP Training--our trainer will come to your location!
· Annual GMP Training--a wide variety of topics to choose from!
· New Employee Orientation--
· Webinar Training--Coming Soon!
Our 20-week Quality Assurance Accreditation Program is targeted to employees with five years or less experience and is conducted by one-hour telephone coaching calls. With this program, you can provide your employees with the skill sets necessary to make quality-conscious and compliant decisions.
Are you up to date on the latest developments in bio-safety and viral testing compliance? Our Biosafety Consulting services can provide you with the expertise needed to design and develop global regulatory product testing strategies at all stages of product development.
Compliance Insight can assist clients in the following areas:
· Project Management--new facility construction, validation planning
· Regulatory Filings--IND, NDA, ANDA, 510k
· 483 Resolution--
· Warning Letter response--
· FDA liaison
· Viral Study Planning and Review
· Cleaning Validation Consultation
· Validation Planning and Review
· Custom Standard Operating Procedures