This exclusive Pack contains 12 courses: 1. ISO/IEC 17025 Update - The Latest Standard for Laboratory Competence 2. Objectionable Microorganisms in Biopharmaceutical Production - Identification and Risk Mitigation 3. Quality Control for Analytical Materials used in Microbiology Laboratories 4. Steam Sterilization Microbiology and Autoclave Performance Qualification 5. Is it Microbiological Method Verification or Validation, or Just Semantics? 6. Environmental Monitoring Investigation Techniques for Effective Contamination Control 7. Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances 8. Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program 9. Aseptic Process Overview and Validation 10. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance 11. Handling OOS Test Results and Completing Robust Investigations 12. Analytical Microbiology - Contract Lab vs In-House Lab - How to Overcome the Corporate Dilemma Total Duration: 15 Hours
This exclusive Pack of webinars contain 11 courses: 1. Good Clinical Practices Review of ICH E6 (R3) Latest Guidance 2. Trial Master File Requirements and Essential Regulatory Documents 3. Selecting and Managing Vendors in Clinical Research 4. Risk Management in Clinical Research 5. FDA’s GMP Expectations for Phase I and First-In-Man Clinical Trials 6. GCP Compliance - Audit Preparation and Inspection Readiness 7. How to Best Document Clinical Evaluation Report (CER) for CE Mark 8. Clinical Project Management 9. Successful FDA Meeting Preparation and Conduct 10. Medical Device Clinical Investigations to the new EU MDR Requirements 11. EU's New Regulation 535/2014 on Clinical Trials - Insights into Effective Clinical Trials Total Duration: 12 Hours
Topic 1: ISO 13485 – MEDICAL DEVICE QUALITY MANAGEMENT SYSTEMS Topic 2: 3-HOUR VIRTUAL SEMINAR ON 510(K) AND PMA SUBMISSIONS PROCESS
This exclusive Pack of webinars contain 5 courses: 1. IEC 62304 for Medical Device Software 2. Drafting a Software V&V Documentation Package and Protocol 3. Validation of Non-Product Software 4. IEC 62304 and Demystifying Software Validation using the Principles of LDLC 5. Medical Device Cybersecurity and FDA Compliance Total Duration: 10 Hours
This exclusive Pack of webinars contain 7 courses: 1. Laboratory Controls – Anticipate the Systems Based FDA Inspection 2. Analytical Method Validation and Transfer 3. Auditing Laboratory Data Systems 4. Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance 5. Handling OOS Test Results and Completing Robust Investigations 6. Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries 7. Establishing a Product Stability Testing Program Total Duration: 12 Hours