Draco Associates Regulatory Affairs & Quality Assurance
Quality Assurance Title

For QA advice, or complete design and management of your QA systems, or something in between, Draco can help.

QA & QM - Quality Management / Lot Release

Set-up, training, and ongoing management or management support of quality assurance processes, including product release

QA At Work

Standard Operating Procedures

Expert development of Standard Operating Procedures (SOPs) and related documents and staff training - including QA Pre-Licensing Reports required for Marihuana for Medical Purposes (MMP) regulations - and/or review of existing SOPs to ensure that they meet current standards and regulatory requirements.

Quality Assurance Systems

Development of compliant quality assurance plans for

  • complaint handling
  • returned goods handling
  • validation
  • recalls
  • document control

Facilities & Temperature Control

Facilities auditing, and development of compliant quality assurance programs and systems for

  • warehousing & storage
  • temperature mapping & monitoring
  • transportation procedures and documentation
QA Technician

Good Manufacturing Practice Audits / GMP Audits

  • Thorough internal GMP self-inspections to GMP standards
  • Quality assurance inspections
  • Quality assurance surveillance plans
  • Surveillance audits and/or support during government audits of contractors and suppliers

Documentation Management

  • Creation and managment of quality assurance documents
  • Detailed specification development
  • Preparation of regulatory documentation
  • Development of document control systems

GMP Training

Effective customized GMP training programs for experienced and new employees

On-Site Support

Available on-site support ensuring operations compliance and available on-site support during inspections by regulatory officials