Quality Assurance Consulting
Identifying effective solutions to complex problems
From importation, routine quality oversight and quality system development, to audit mitigation, training and facility validation; Innomar specializes in identifying effective solutions to complex problems. We can help you build a quality system that is right for you, and will allow you to effectively navigate the ever changing world of quality compliance.
We have multi-jurisdictional quality expertise in the following sectors:
Active Pharmaceutical Ingredients (APIs)
Pharmaceuticals
Biologics
Medical Devices (ISO 13485, MDSAP)
Natural Health Products
Cosmetics
Quality Assurance and Compliance Services
Compliance
- Quality Investigations (Deviations, OOS, CAPA, Complaints, etc.)
- Health Canada / FDA Remediation
- Quality Assurance Gap Analysis
- Internal Audits / Self Inspections
- Product Release
- Vendor Qualification (Suppliers, QC Laboratories, etc.)
- Backlogs (Batch Records, Deviations, Change Controls, Complaints, etc.)
- Quality System Development
- Quality Agreements
- APQR / YBPR Preparation
Audits
- 21 CFR Part 210 & 211 (FDA GMPs)
- Health Canada GMPs (Drug, Device, NHP)
- Health Canada GPPs (Cannabis)
- Medical Devices (ISO 13485 MDSAP)
- Fabricators (Pharmaceuticals, Biologics, APIs, Devices)
- Quality Control Laboratories
- Packagers / Labelers
- Distribution / 3PL
- Importers
Importation
- Act as a company’s QC Unit
- Establishment Licensing Application and Amendments
- Importer of Record Services
- Host Health Canada GMP Inspections
Validation
- Temperature Mapping
- Shipping Validation
- Facility / Equipment Validation
- Validation Protocol / Plan Development
Training
GMP Fundamentals
Medical Device Fundamentals
ISO 13485:2016 MDSAP
Annual GMP Training
Preparing for a Regulatory Inspection
Quality Auditing
Good Documentation Practices
Importation / Establishment Licensing
Our Quality Assurance Consulting Leader
Stuart du Kamp, Senior Director, QA GMP Services
In his present role as Senior Director, QA GMP Services, Stuart is responsible for the quality assurance oversight of Innomar’s 3PL, specialty and wholesale activities nationwide. Stuart also leads a team of seasoned quality assurance professionals providing consulting services across the full range of pharmaceutical platforms. Stuart brings over 30 years of experience in the pharmaceutical industry, including over 20 years in Quality Management, 12 years within CMO organizations, and specific experience within the API, sterile, biotechnology, pharmaceutical and medical device sectors. He has a demonstrated record of successfully melding quality compliance with business goals, leveraging his extensive expertise in quality risk management. Stuart has served on a number of industry working groups and has developed a reputation as an 'ideas' guy, and an innovator, who thrives in environments that demand pragmatic, cost effective and timely solutions to complex problems.
