Exemplar Global – Accredited & Industry-Focused Trainings |
| Training Title | Duration | Availability | Request a Quote | Enroll |
| Risk-Based Best Practices in Change Control | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Deviations, Corrective & Preventive Actions (CAPA) | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| GMP Fundamentals | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Advanced GMP Practices | 3 Days | Pharma/ Biotech | ✅ | ✅ |
| Train-the-Trainer: GMP Instructor Development | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Quality Risk Management with Practical Case Studies | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Behavioral GMP & Quality Culture in Pharmaceutical Manufacturing | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Root Cause Investigation & Human Error Prevention Techniques | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Annual Product Review (APR) and Trend Analysis | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Process Validation & Lifecycle Approach (FDA, EMA, PIC/S, TİTCK) | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Sterile Manufacturing | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Supplier Qualification | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Technology, Test Method & Product Transfer | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Computerized System Validation (CSV) | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Cleaning Validation & Lifecycle (Including PDE/ADE Concepts) | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based HVAC, Water, Steam & Gas Systems Validation | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Environmental Monitoring & Contamination Control Strategy for Sterile Manufacturing | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Analytical Method Validation & Equipment Qualification | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Best Practices in Microbiology Laboratory | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Temperature Mapping for Warehouses & Cold Rooms | 2 Days | All Pharma/ Biotech | ✅ | ✅ |
| GDP-Compliant Route Qualification for Pharmaceutical Transport | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| GDP-Compliant Vehicle & Warehouse Qualification | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Sampling Plans | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Advanced Stability Studies | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Facility Layout Design & GMP-Compliant Engineering Applications | 3 Days | Pharma/ Biotech | ✅ | ✅ |
| 21 CFR Part 11 & EU GMP Annex 11: Electronic Records and Signatures | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Data Management & Data Integrity (with Case Studies) | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Elemental Impurities & Pharmaceutical Impurity Profiling | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Facility Management During Shutdown Periods | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Statistical Process Control (SPC) in Pharma & Biotech | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Best Practices in Quality Control Laboratories | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Best Documentation Practices for Pharmaceutical QMS | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Effective Training Design for Pharmaceutical & Biotechnology Industries | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Complaint Handling | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Out-of-Specification (OOS) & Out-of-Trend (OOT) Management | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Risk-Based Product Recall Management | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Operational Excellence (OPEX) Best Practices – Pfizer, Novartis, Novo Nordisk, Takeda, Abbott, Roche, Bayer | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Internal & Lead Auditor Programs (GMP, GDP, GQCLP, Data Integrity, Cleanroom) | Various | Pharma/ Biotech | ✅ | ✅ |
Sterile & Biopharmaceutical Trainings |
| Training Title (EN) | Duration | Availability | Request a Quote | Enroll |
| Sterile Product Development & Dosage Forms | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Sterile Product Technology Transfer | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Container-Closure Integrity Testing & Packaging | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Stability Studies for Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Operational Excellence (OPEX) in Sterile Products | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Air & Water Quality in Sterile Products | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Quality Risk Management in Sterile Products | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Visual Inspection in Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Filtration in Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Sterilization Methods & Validation | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Environmental Monitoring & Contamination Control for Sterile Products | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Microbial Flora Determination in Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Pyrogen & Endotoxin Testing in Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Bioburden, Sterility & Sterility Assurance | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Terminal Sterilization Methods | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Isolator & RABS Technologies & Containment | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Aseptic Process Simulation | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| PUPSIT (Product, Unit, Process Simulation & Integrity Testing) | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Lyophilization | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Single-Use Systems in Biopharmaceutical Manufacturing | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Biopharmaceutical Facility QMS Implementation & Management | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Downstream & Upstream Processing | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Master Cell Bank & Working Cell Bank | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Cell Culture & Protein Expression | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Filtration & Purification in Biopharmaceuticals | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Data Integrity & Management in Biopharmaceuticals | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Chromatographic Data System Validation in Biopharmaceuticals | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Analytical Method Validation in Biopharmaceuticals | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Process Validation in Biopharmaceuticals (FDA & EMA Approaches) | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Cleaning Validation in Biopharmaceuticals | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Bioreactor Design & Fermentation | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Biopharmaceutical Manufacturing Methods & Risk Assessment | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Biopharmaceutical Product Licensing & Regulatory Pathways | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Biosimilars & Biobetters | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| CIP & SIP (Clean-In-Place / Sterilization-In-Place) in Biopharmaceuticals | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Biopharmaceutical Facility Design & Validation | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Immunogenicity | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| International Guidelines, Regulations & Expectations for Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| PIC/S GMP Guide & Annexes for Sterile Products | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Lean Biopharmaceutical Manufacturing | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Worker Health, Safety & Environmental Management in Biopharmaceutical Manufacturing | 1 Day | Pharma/ Biotech | ✅ | ✅ |
| Preparing Sterile Product Facilities for International Audits | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Supply Chain Management in Sterile Products | 2 Days | Pharma/ Biotech | ✅ | ✅ |
| Transport, Storage & Distribution Requirements for Biopharmaceutical Products | 2 Days | Pharma/ Biotech | ✅ | ✅ |
