The GMP board game that tests and improves your GMP compliance, knowledge, attitude and awareness!
The GMP Handbook for pharmaceuticals
Quality Systems Handbook for MedDev
E-books: US and EU regulations
GMP translations (FR, SE, DK)
Search tool and document library. Find your way in regulations, guides and other reference documents.
Even though we are specialized in developing and presenting compliance training related to current GMP regulations and FDA requirements, we also offer consultancy across a wide range of areas.
As well as our specialist trainers, we have a network of consultants experienced in the many aspects of the pharmaceutical supply chain – from raw material supplier to delivery of the finished product to the pharmacy.
For more information, specify your needs and contact us via e-mail info@key2compliance.com or phone +46-(0)8 544 811 60.
• Internal GMP Audits
• Mock FDA Inspections
• Pre-approval (PAI) Inspection Audits
• Contractor Audits
• Audit Program Development
• GMP Compliance Evaluation
• Research and Development Compliance programs
• Change Control System
• Quality Assurance Programs
• Document Control System
• Product Annual Review Program
• GMP & Technical Training Programs
• Batch Record Review System
• Process Deviation Investigations
• Product Failure Investigations
• Batch Release/Rejection Evaluation
• Responses to FDA Letters & FD-483’s
• Responses to FDA Regulatory Actions
• Correction of FDA Observations
• Representation at FDA Meetings
• Design of Validation Studies
• Review of Validation Protocols & Reports
• Validation Data Review
Facilities:
• Compliance Review of Facilities & Equipment Design
• Coordination for FDA Review & Approval
Key2Compliance AB and EuroGMP AB • Tjädervägen 10 • SE-181 56 Lidingö • SWEDEN • Tel: +46-(0)8-544 811 60 • e-mail: info@key2compliance.com
