Looking for private QA and GMP training for your organisation?

SeerPharma can help by delivering a standard course or a customised training course tailored to your specific training needs. Standard courses include a mix of theory and interactive workshops that address ‘real-world’ scenarios from industry. Customisation options include mixing-and-matching courses or modules from other courses and modifying workshops to case studies that are directly applicable to your operations.

We also offer flexible delivery modes where we can deliver in-house training on-site or we can do virtual-classroom training online via Zoom.

Listed below are some of the most popular courses we deliver in public and private sessions.

Contact us to discuss your training needs on these or other topics and explore how we can help you.

MEDICAL DEVICE TOPICS
Medical Device: Roadmap to Market (Introduction to Medical Device Regulatory Requirements)
Software as a Medical Device (SaMD) - Lifecycle, CSV and QMS Compliance
ISO 13485 Introduction (2 half days)
ISO 13485: A Practical Approach to QMS For Medical Devices (2-days)
ISO 13485: Quality Management System (QMS) for Medical Devices Workshop (4-days)
ISO 14971 - Risk Management for Medical Device

QUALITY SYSTEM, RISK Management and VALIDATION TOPICS
Behavioural GMP – Minimising Human Error
Product Quality Reviews (PQRs)
Release for Supply (RFS) – Responsibilities of Authorised Persons (APs)
Contamination Control
Out of Specification (OOS) Handling
Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA)
Supply Chain Management
Supplier Quality Assurance (QA) – A Strategic Approach
Quality Risk Management (QRM): Process Risk Assessment
Risk Assessment: Quality and Compliance
Internal Audits – A Key to Your Quality System
How to Prepare for an Inspection / Audit
Post Market Monitoring and Pharmacovigilance
Validation – A Roadmap to Getting it Right First Time
Equipment Cleaning Validation
Computer System Validation (CSV)

GxP TOPICS
Good Aseptic Practices (GAP)
Annex 1 Changes (PIC/S Guide to GMP) - Manufacture of Sterile Medicinal Products
GMP - What You Need to Know (PIC/S GMP Guide PE 009)
GMP for Engineering
GMPs for Phase I Cell-based Therapies
GMPs for Tissue Banks
Good Warehouse Practice
Good Writing Practices for Efficiency and Error Proofing

IT, DATA AND TECH TOPICS
Cloud Computing for Life Sciences – Quality Paradigm Shift
Software as a Medical Device (SaMD) - Lifecycle, CSV and QMS Compliance
Computer System Validation (CSV)
Data Integrity (DI) – Identify and Address Your Vulnerabilities
MTP 4.0 - Industry 4.0 for MedTech, Biotech & Pharma