T3GxPedia Consulting – your Partner for Quality and Compliance
GxP & Quality Excellence for Pharma and Medical Devices
Consulting, interim management and training along the entire product life cycle.
We support companies in complying with quality and regulatory standards. Our expertise extends over the entire product life cycle. We offer individual solutions for challenges in the pharmaceutical industry and medical devices.
about T3GxPedia
your Partner for Quality and Compliance
We support companies in complying with quality standards. Our expertise spans the entire product lifecycle. We offer customized solutions for challenges in the pharmaceutical and medical device industry.
More then 50
successful projects!
100 %
satisfied customers!
More then 40
years of experience!
Consulting
We support companies with tailor-made consulting services in GxP, medical devices and quality management – from strategic setup to operational implementation:
- GMP Audits and Mock Audits for GMP & Regulatory Compliance of EU-GMP, US-GMP and ISO-Standards (9001, 13485,14971), Inspection Readiness
- Due diligence audits
- Quality Management (QMS): System Review, Implementation, Process Design, SOPs, Process Maturity/Excellence
- Risk & Investigations: QRM, Deviation Management, OOS/Investigation Support
- 3rd Party Management and Supplier Qualification
- Lifecycle Support: Development → Production → Market Launch, Production Optimization, Regulatory Interpretation/Implementation
- Medical Devices: implementation of CFR and MDR requirements
Interim-Management
Experienced interim managers for effective project implementation in your company.
We take responsibility in QA, QC and project organizations – stabilizing in critical phases, effective in transformations, audit readiness or remediation.
In-house training & workshops
Training at a high level – practice-oriented and strong in implementation.
Formats:
- Webinars (live or remote, and interactive) – convenient, focused, Q&A included
- In-house trainings – tailored to your processes/products and needs
- Individual Coaching – 90-minute modules, highly interactive, concrete cases from your everyday life, e.g.: QP, Head of Quality Control / Head of Manufacturing - Overcoming Challenges in daily business
Training topics:
- GMP Basics,
- Validation,
- Auditor training,
- Deviation/OOS/Change Control and Complaints
- Medical Devices/MDR,
- documentation,
- QP, Head of Quality Control / Head of Manufacturing - Overcoming Challenges
- CMO Management
- Quality Risk Management (ICH Q9)
- Validation of Analytical Methods (ICH Q2a)
- Quality of Biotechnological products (ICH Q5)
- Specifications (ICH Q6)
- Change Control (and other modules as required)
- EU GMP Annex 1, Annex 11, Annex 15, Annex 16
- Other trainings on demand.
Regulatory Compliance
Support in the implementation of GMP, MDR, ISO, and FDA requirements.