The 2015 National GMP & Validation Forum
A Better Pharmaceutical Manufacturing Industry by Design – the National GMP & Validation Forum.
Selected GMP and Validation presentations from the 2015 National Forums are available to download here, the spirit of the event was to share the information.
Beginning in 2011 as the National Validation Forum, this started out as not-for-profit event and has been facilitated by PharmOut and supported by the TGA (for the first two years) and most importantly, local industry.
Support for the event has grown steadily each year, including around the country presentations, as well as in New Zealand and Hong Kong.
Selected Presentations
Day 1
Plenary Presentations
- D1.P1. Open the Forum
- D1.P3. GMP_Update
- D1.P4. EU GMP Evolution or Revolution
- D1.P5. Basic_Principles_API_RIsk_Assessment_EMA_guideline_requirements
- D.1P6. Data_Integrity
- D1.P7. Annex_15_New_Requirements_&_Approach
Track 1 GMP Presentations
- D1.T1.2._1&2_Controlling facility contamination
- D1.T1.2.3._QRM_not_all_about_assessment
- D1.T1.3.1. PICS update
- D1.T1.3.2_EU PICS_GMP_update_part_1
- D1.T1.S3.P3_WHO_GMP_update part 2
Track 2 Cross Contamination Presentations
- D1.T2.2.1 Understanding cross contamination 2015-07-17
- D1.T2.2.2_Cross contamination control 2015-08-09
- D1.T2.2.3 Using fly through and 3D to visualise contamination risk
- D1.T2.3.1 Energy Saving
- D1.T2.3.2 GJF-T2-04 HVAC Failure Modes
- D1.T2.3.3 GJF-T2-05 HVAC Cross-Contamination Control
Track 3 Data Integrity and Computer Systems Presentations
- D1.T3.S2.P1_Data Integrity An Old Problem New Focus
- D1.T3.S2.P2 New MHRA – Data integrity guidance what this means in practical terms
- D1.T3.S3.P2 – Annex 11 and Part 11
Track 4 Validation Presentations
- D1.T4.2.1 – Ashley Isbel – Annex 15 Practical Implications
- D1.T4.2.2 – EMA and FDA approaches to process validation
- D1.T4.3.1 (Getinge) – GMP Washing
- D1.T4.3.2 Analytical Method Validation
- D1.T4.3.3 Cleaning Validation – Old vs New Methodology
Day 2
Track 1 GMP Presentations
- D2.T1.1.1 GMP EU Chapter 6_Quality Control
- D2.T1.1.2 US FDA Request for Quality Metrics
- D2.T1.1.3 Internal and External auditing tips ISO 19011
- D2.T1.2.1 ICH Q7 Update
- D2.T1.2.2 GMP_considerations_design_API_plant
- D2.T1.2.3 New GMPs for Active Substances and Excipients
- D2.T1.3.1 NVF Compounding Pharmacies USP 797
- D2.T1.3.2 Design considerations for TGA pharmacies
- D2.T1.4.1 Deviation Incident Non-conformance Systems
- D2.T1.4.2 Designing and building effective automated Change Control Systems
- D2.T1.4.3_CAPA and Root Cause Analysis
Track 2 Cross Contamination Presentations
- D2.T2.1.1 Basic Pharmacokinetics for Toxicology Assessment
- D2.T2.1.4_Cross Contamination Control
- D2.T2.2.1 Introduction to Toxicology Assessment
- D2.T2.3.1 Case Study – Venlafaxine
- D2.T2.4.1 Airlocks
- D2.T2.4.2 Facility Renovation
- D2.T2.4.3 ISO Cleanroom Standards Update
Track 3 Data Integrity and Computer Systems Presentations
- D2.T3.2.2 SharePoint the next eQMS solution
- D2.T3.4.P2 End User Applications
- D2.T3.S1.P1 Cloud and Outsourcing
- D2.T3.S1.P2. Quality Risk Management
- D2.T3.S2.P1 Mobile Apps
- D2.T3.S3.P1 Mobile App Workshop Compliance Challenges
- D2.T3.S3.P2 ERP Validation
- 2D2.T3.S4.P1 10 things every CSV URS should consider
Track 4 Validation Presentations
- D2.T4.1.1 Writing an Effective FS&E URS
- D2.T4.1.2 Scale up of Biotech using QbD
- D2.T4.1.3 Practical example of technical transfer QbD
- D2.T4.2.1 Continuous & Continued Process Verification
- D2.T4.2.3 Qualification of Temperature Sensitive Storage Areas
- D2.T4.3.3 Temperature and humidity mapping of cleanrooms
- D2.T4.4.1 EN285 Live Steam Testing
- D2.T4.4.3 Design Considerations for Controlled Environment Spaces with Close Control