Presentations by Tim Sandle


Listed below are some of the presentations delivered by Tim Sandle.

To contact Tim about a presentation, conference or webinar, contact Tim via email.

PRESENTATIONS
1.      'Bacterial Endotoxin Test: Introducing Methodology' to the Parenteral Society One Day Seminar on LAL Testing, 14th March 2002, Manchester
2.      ‘Future  Direction of Pyrogen Testing’ to PharMIG AGM, November 2002, Peterborough
3.      ‘Monitoring – What, When and How Often?’ to Pharmaceutical Cleanrooms, Cambridge, 18th March 2003
  1. ‘Sterility Testing – A Practical Approach’, PharMIG Microbiological Methods
  2. Validation Conference, St. Albans, 4th June 2003
  3. ‘Risk Assessment in the Pharmaceutical Industry’, AUDITS 13, Brussels, 16th    September 2003
  4. ‘Current Practices in Sterility Testing’, Institute of Validation Technology Microbiology Event of the Year’, December 2003, Dublin
  5. ‘Practical Approaches to Sterility Test Validation’, PharMIG Microbiological Methods Validation Conference, Dublin, 25th March 2004
9.      ‘Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System Qualification’, PharMIG Endotoxin Course, Waltham Abbey, 3rd June 2004
10.  ‘Microbiological Environmental Monitoring in an Isolator Used for Aseptic Filling or Sterility Testing’, AUDITS 15, Brussels, 21st September 2004
11.  ‘Environmental Monitoring Risk Assessment’, Institute of Validation Technology Microbiology Event of the Year’, November 2004, Amsterdam
12.  ‘Constructing a Viable Environmental Monitoring Programme Using a Risk Assessment Approach’, Pharmaceutical Cleanrooms 2005, 6th September 2005, Cambridge
13.  ‘Hot Topics in Pharmaceutical Microbiology’, two interactive sessions, PharMIG Conference, 23rd November 2005
14.  ‘NHS Pay Reform’, National Institute of Biological Standards and Control, South Mims, 18th January 2006
15.  Hot Topics in Pharmaceutical Microbiology’, interactive session, PharMIG Irish Conference, Cork, 8th June, 2006
16.  ‘Distribution of Microbiological Data’, PharMIG Irish Conference, Cork, 7th June, 2006
17.  NHS financial crisis and the Blood Service’, NHS Together, Cambridge, 4th March 2007
18.  ‘Managing a Microbiology Laboratory Training Programme’, presenter on laboratory training programmes, 29th March 2007, PharMIG Training Event, Derby
19.  ‘Applying Failure Mode and Effects Analysis (FMEA) to a Sterility Testing Isolator: A Case Study’, PharMIG Risk Based Management in Pharmaceutical Microbiology, 27th June 2007
20.   ‘Managing a Microbiology Laboratory Training Programme’, presenter on microbiology laboratory training programmes, 27th September 2007, PharMIG Training Event, Dublin
21.  ‘Best Practices in Microbiological Quality Control and Documentation’, workshop presenter on good documentation practises, 16th October 2008, Pharmig event, Northampton
22.  Best Practices in Microbiological Quality Control and Documentation’, workshop presenter on good quality documentation practises, 1st April 2009, Pharmig event, Cork, Republic of Ireland.
23.  ‘Managing a Microbiology Laboratory Training Programme’, presenter on microbiology laboratory training programmes, 10th June 2009, PharMIG Training Event, Dublin
24.  ‘How to justify doing less monitoring, sampling and testing, and still pass a regulatory inspection’, Pharmig Annual Conference, Nottingham. Session run twice on 18th and 19th November 2009.
25.  ‘Contamination control and pharmaceutical microbiology’, two day course co-hosted with Dr Nigel Halls, run for Nobel Farama, Turkey, 5th & 6th January 2010
26.  Best Practices in Microbiology Training, two sessions, Pharmig Annual Conference, Nottingham. Session run twice on 24th and 25th November 2010
27.  Regulatory Developments: Key Points for Microbiology, Pharmig Annual Conference, Nottingham. Session run twice on 24th and 25th November 2010
28.  Cleanrooms and Air Contamination, VIENNI TRAINING, Prune, India, 6th January 2011
29.  ‘The Use of Risk Assessment in the Pharmaceutical Industry – the application if FMEA to a Sterility Testing Isolator: A Case Study’, presented at Pharmaceutical Microbiology Conference (SMi Group), Copthorne Tara Hotel, London, 17th January 2011
30.  ‘Approaching Sterility Testing’, Hulst Pharma Test Expo, Cologne, Germany, 9th February 2011
31.   'Developments in Regulatory Requirements', ECA 4th Microbiology Conference, Prague, 4th May 2011
32.  'Environmental Monitoring: sterile / non-sterile', ECA 4th Microbiology Conference, Prague, Czech Republic, 5th May 2011
33.  "How to Justify Doing Less Monitoring, Sampling and Testing and Still Pass a Regulatory Inspection", PDA's 6th Annual Global Conference on Pharmaceutical Microbiology, Bethesda, MD, USA, 18th October 2011
34.  Regulatory Update for Microbiology in 2011, Pharmig Annual Conference, Nottingham. 16th November 2011.
35.  'A risk based approach to environmental monitoring frequencies', ECA 5th Microbiology Conference, Frankfurt, Germany, 10th May 2012
36.  Regulatory Updates: 2012, Pharmig Irish Conference, Cork, Ireland, 14 June 2012
37.  USP Chapter 1116: environmental monitoring changes, Pharmig Irish Conference, Cork, Ireland, 14 June 2012
  1. ‘Review of Cleanroom Microflora’, NHS Pharmaceutical Quality Assurance Service, Annual Symposium for Technical Services, 25th September 2012, The Ashford International Hotel, Kent, UK
  2. 'Fungal contamination of pharmaceutical products', Pharmaceutical and Healthcare Sciences Society (PHSS) Annual Conference, 11th October 2012, Winchester, UK
40.  USP Chapter 1116: trends in environmental monitoring, Pharmig Annual Conference, Chipping Norton, UK. 6th November 2012
41.  Webinar 'Human Microbiome Project', Microbiology Network (with Tony Cundell and Scott Sutton), 5th March 2013.
42.  'Fungi in pharmaceutical manufacturing', European Compliance Academy Microbiology Conference, Copenhagen, Denmark, 25th April 2013
43.  'USP 1116 and its impact upon pharmaceutical microbiology', Pharmig webinar, 1st May 2013
44.  'The use of control strains for the quality control of culture media', American Pharmaceutical Review Webinar, 14th August 2013 (with Liz Kerrigan of ATCC)
45.  'Hospitals, Water Systems and Contamination, NHS QA Symposium, Chester, UK. 24th September, 2013
46.  'Rapid Microbiology Methods and Risk Assessment in the Pharmaceutical Industry', American Pharmaceutical Review Webinar, 16th October 2013 (with Jackie Horrige, BioVigilant)
47.  'The Human Microbiome Project and Implications for Pharmaceutical Microbiology', PDA 8th Microbiology Conference, Bethesda, MD, USA, 21st October 2013
48.  'Best Microbiological Practices for cleanroom gowns, gloves and masks', Pharmig Annual Conference, 21st November, 2013
49.  'Implications of fungal contamination of pharmaceutical products', Pharmig Annual Conference, 21st November, 2013

  1. Best practices in managing microbial excursions and managing out of specification events, webinar for European Pharmaceutical Review, 3rd December 2013
  2. Fungi and pharmaceutical manufacturing, webinar for Pharmig, 19th February 2014
  3. Fungal contamination of pharmaceuticals products, Making Pharmaceuticals, National Motorcycle Museum, Birmingham, 29th April, 2014
  4. Human Microbiome Project, European Compliance Academy, Prague, May 2014
  5. Essential Components for Implementation of a Robust Environmental Monitoring Program (with Anne Connors, Merck Millipore), American Pharmaceutical Review, webinar, 9th July 2014
  6. Contemporary issues in pharmaceutical microbiology, NHS QA Symposium, Kenilworth, UK, 17th September 2014
  7. Media Fill Trials for Aseptic Process Control in Sterile Pharmaceutical Manufacture, webinar for Cleanroom technology (with Colin Booth, ThermoFisher), 24th September 2014
  8. Key points for Cleanroom Disinfection, Gerpac 17th Conference, Presqu’ile de Giens, Hyères, France, 2nd October 2014. (DOI: 10.13140/2.1.5029.76)
  9. Constructing an environmental monitoring program, BioMonitoring Seminar, Environmental Monitoring & Risk Analysis in pharmaceutical Industry, Evoluon, NL-Eindhoven, Netherlands, 9th October 2014
  10. Risk assessment for environmental monitoring, BioMonitoring Seminar, Environmental Monitoring & Risk Analysis in pharmaceutical Industry, Evoluon, NL-Eindhoven, Netherlands, 9th October 2014
  11. An environmental monitoring workshop, BioMonitoring Seminar, Environmental Monitoring & Risk Analysis in pharmaceutical Industry, Evoluon, NL-Eindhoven, Netherlands, 9th October 2014 (with Dr. David Roesti).
  12. Cleanroom contamination and disinfection, Pharmig Cleanroom seminar, 28th October 2014, Birmingham, UK
  13. Implications of the human microbiome for cleanrooms, Pharmig Annual Conference, Nottingham, UK
  14. Risk Based Environmental Monitoring & Lean Manufacturing, 25th February 2015, Novatek International, Webinar.
  15. Best practices for an environmental monitoring programme, Making Pharmaceuticals, National Motorcycle Museum, Birmingham, U.K. April 28, 2015
  16. Risk assessment and microbiological risks to pharmaceuticals, Making Pharmaceuticals, National Motorcycle Museum, Birmingham, U.K. April 28, 2015
  17. Webinar - Microbiological Risk of Personnel and Cleanrooms - 28th May 2015
  18. Webinar - Disinfection/Sanitisation Processes: cGMP for Cleaning and Disinfection, 25th June 2015, Pharmig - 25th June 2015
  19. The Problem with Spores in Aseptic Units, presented at 'Sporicides – As Part Of Your Transfer Process' - a Pharmig ./ NHS joint symposium, Birmingham, U.K. on 1st July 2015
  20. Sporicidal Products - a problem of definition and control, presented at 'Sporicides – As Part Of Your Transfer Process' - a Pharmig ./ NHS joint symposium, Birmingham, U.K. on 1st July 2015
  21. Environmental control and environmental monitoring, presented at King's College Hospital NHS Trust, London, U.K., on 24th July 2015
  22. Validation of an Agar Plate Active Microbial Air Sampler According to ISO 14698, Merck webinar, 16th September 2015
  23. The future of ISO 14698, Merck webinar, 16th September 2015
  24. Microbiology Laboratory Myths, 10th PDA Global Microbiology Conference, Bethesda, MD, USA, 19th October 2015
  25. Ask the experts panel, 10th PDA Global Microbiology Conference, Bethesda, MD, USA, 19th October 2015
  26. Disinfection Processes for Pharmaceuticals and Surface Sampling on Sanitized Surfaces, Merck webinar, broadcast in Europe and North America (2 sessions) on 22nd October 2015
  27. Bioburden control and objectionable organisms (with Andy Martin), Pharmig Microbiology Conference, Nottingham, U.K., 25th November 2015
  28. Environmental Monitoring Risk Assessment and the Lean Approach, Pharmig Microbiology Conference, Nottingham, U.K., 26th November 2015
  29. Best practices for aseptic operator practice and gowning, Pharmig Microbiology Conference, Nottingham, U.K., 26th November 2015
  30. ISO 14644 Revision to Parts 1 and 2 (2015 updates), Pharmig webinar, 4th February 2016
  31. Overview of environmental monitoring regulations, Pharmig Environmental Monitoring Course, The Oxfordshire Hotel, Oxford, 3rd March 2016
  32. Environmental monitoring incubation strategies, Pharmig Environmental Monitoring Course, The Oxfordshire Hotel, Oxford, 3rd March 2016
  33. Bacterial and fungal spores - aseptic processing risks, Pharmig & NHS Sporicidal Meeting, The Oxfordshire Hotel, Oxford, 4th March 2016
  34. Selection of disinfectants and sporicides, Pharmig & NHS Sporicidal Meeting, The Oxfordshire Hotel, Oxford, 4th March 2016
  35. Environmental monitoring trending for risk mediation and lean manufacturing, PDA Europe, 10th May 2016 - webinar
  36. Environmental monitoring and microflora - key points, ECA Pharmaceutical Microbiology Conference, Barcelona, 11th May 2016
  37. Investigating Sterility Test Failures, Joint Pharmaceutical Analysis Group, Royal Society for Chemistry, London, 12th May 2016
  38. Environmental monitoring incubation strategies, Pharmig Irish Conference, Fota Island Hotel, Cork, 18th May 2016
  39. Best practices in pharmaceutical gowning, at: PHSS Sterile Products Manufacture June 9, 2016, Hallmark Hotel Manchester Airpor
  40. Best practices for investigating sterility test failures, Pharmig webinar, 6th September 206
  41. Depyrogenation Studies, A3P, Lyon, 18th September 2016
  42. Best practices with microbiological culture media, Pharmig 24th Conference, Nottingham, UK, 17th November 2016
  43. Cleanroom contamination; the Problem Spores and the need for Sporicides, Pharmig conference, Wednesday 15th Feb 2017 - Nailcotte Hall Hotel, Berskwell, Warwickshire
  44. Introduction to cleanrooms, Thursday 16th Feb 2017- Nailcotte Hall Hotel, Berskwell, Warwickshire
  45. Current regulations for environmental monitoring, Wednesday 24th May 2017, Pharmig conference, Portmarnock Hotel & Golf Links, Co. Dublin, Ireland
  46. Selecting culture media for environmental monitoring, Wednesday 24th May 2017, Pharmig conference, Portmarnock Hotel & Golf Links, Co. Dublin, Ireland
  47. Approaching depyrogenation, Pharmig webinar, 10th August 2017
  48. ‘Fungal Contamination in Pharmaceutical Products and Cleanroom Risk’, webinar for Pharmig, 4th October 201
  49. Environmental monitoring - limitations, incubating, and trending, 18th October 2017, Pharmig / Samples H conference: Hot Topics in Pharmaceutical Microbiology for the Adriatic Region, Otocec, Slovenia
  50. Training in cleanroom contamination, disinfection, and cleaning techniques, 18th October 2017, Pharmig / Samples H conference: Hot Topics in Pharmaceutical Microbiology for the Adriatic Region, Otocec, Slovenia
  51. How to manage sterility test issues and failure investigations, 18th October 2017, Pharmig / Samples H conference: Hot Topics in Pharmaceutical Microbiology for the Adriatic Region, Otocec, Slovenia
  52. Quantitative determination of endotoxin, Pharmig open discussion session, Pharmig Annual Conference, Oxfordshire, UK, 30th November 2017
  53. Risk Based Approach to Environmental Monitoring, webinar for Compliance Online, 19 December 201
  54. Sterility test failure investigations, webinar for Compliance Online, 23 Jan 2018
  55. Review of EU GMP Annex 1, webinar for Compliance Online, 15th March 2018
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