Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

PRESENTATIONS


 

Presentations of Destin LeBlanc related to cleaning and cleaning validation:

1. "Good Cleaning Validation Practices", 2-day and 3-day seminars, Cleaning Validation Technologies, presented numerous times (1998-2016).

    2. I have presented numerous times one-day and two-day seminars entitled "Basic Concepts in Cleaning and Cleaning Validation" (1996 to 2007). These include both public seminars as well as on-site seminars for individual companies, and have been presented in North America, Europe, Asia, and Australia.

      3. The same seminar, "Basic Concepts in Cleaning and Cleaning Validation" has also been presented numerous times as part of the PDA Training and Research Institute, of which I was a faculty member (1998-2008).

        4. The same seminar, "Basic Concepts in Cleaning and Cleaning Validation" has also been presented three times under the auspices of the Pharmaceutical Sciences Group of Canada (1998-1999).

          5. A two-hour presentation entitled "Cleaning Validation" has been presented as part of the FDA Basic Drug School, Systems-based Inspections and PAI training numerous times (1998-2016).

          6. "Life-Cycle Approach for Cleaning Validation?", presented at PDA Southeast Chapter Dinner and Dialogue, Tampa, FL, August 25, 2014.

            7. I have presented monthly webinars (typically 2 hours) on the following subjects as part of the webinar series by the Tungsten Shield Group (2011-2015): 

            Sampling Methods and Sampling Recoveries for Cleaning Validation                                                            Grouping Strategies for Cleaning Validation                                                                                                   Microbial Issues in Cleaning Validation                                                                                                            Cleaning Validation Fundamentals                                                                                                                   Limits for Actives for Cleaning Validation                                                                                                         Analytical Methods for Cleaning Validation                                                                                                      Maintaining Cleaning Processes in a State of Control                                                                                     How the New FDA Process Validation Affects Cleaning Validation                                                                 Health-based Limits                                                                                                                                          Dealing with Indirect and Non-Prodcut Contact Surfaces                                                                                TOC as an Analytical Method for Cleaning Validation                                                                                      Special Cases in Expressing and Calculating Limits                                                                             Design of Automated and Manual Cleaning Processes                                                                    Validation of Automated and Manual Cleaning Processes                                                                Preparing for an Cleaning Validation Inspections

             8. I have presented monthly webinars (usually 1-2 hours) on the following subjects on the dates indicated: 

            "Are We Setting Limits Correctly? (August 19, 2008)
            "PAT for Cleaning Processes" (September 25, 2008)
            "Utilizing ICH Q7A Principles in a Risk-based Approach" (October 23, 2008)
            "Limits Based on Stratified Sampling" (November 20, 2008)
            "Impact of Degradation on Biotech Cleaning Validation" (December 18, 2008)
            "Implications of FDA Process Validation Guidance for Cleaning Validation Programs" (Jan. 22, 2008)
            "Understanding and Improving Swabbing and Swab Recovery" (February 26, 2009)
            "Product Grouping for Non-Dedicated Equipment" (May 26, 2009)
            "Cleaning Validation for Manual Cleaning" (May 23, 2009)
            "Limits Based on Criteria Other than a Dose" (May 14, 2009)
            "Use of TOC for Cleaning Validation" (June 18, 2009)
            "Proper Use of Rinse Sampling" (July 16, 2009)
            "Bioburden and Other Microbiological Issues in Cleaning Validation" (August 20, 2009)
            "Cleaning Validation for Lyophilizers" (September 24, 2009)
            "Failure Mode Effects Analysis for Cleaning Processes" (November 10, 2009)
            "Visually Clean for Cleaning Validation" (December 10, 2009)
            "Streamlining Cleaning Validation" (January 21, 2010)
            "Using Dose-Based Limit Calculations" (February 25, 2010)
            "Design and Development for Cleaning Processes" (May 22, 2010)
            "Analytical Methods for Cleaning Validation" (May 25, 2010)

            9. A two-day advanced topics training was held as part of the Echo Consulting Group “Validation Summit” in Puerto Rico on April 13-14, 2016. Topics were “Health-Based Limits”, “Dealing with Indirect Product Contact Surfaces”, “Dealing with Non-Product Contact Surfaces”, “Cleaning and Safety Issues for Highly Hazardous Actives”, “Simplifying Sampling Recovery Studies”, “Cleaning Validation for Continuous Manufacture”, and “Lifecycle Approach for Cleaning Validation”.

            10. "Health-based Limits" and "Carryover Calculations & Determining Compliance", presented at IVT Cleaning Validation Conference, August 19, 2015, Philadelphia, PA.

            11. A two-day advanced topics training as held as part of the Echo Consulting Group "Educational Summit." Topics were Cleaning Validation Introduction and History, Utilizing TOC as an Analytical Method, Worst-Case Protocol Challenges, Sampling Methods, Issues in Recovery Studies, Dealing with Extraneous Peaks, Issues in Designing and Validating Manual Cleaning Processes, Setting Residue Limits (Chemical), Health-based Residue Limits, Microbial Issues (Limits and Clean Hold Time), Issues with Non-Direct-Product Contact Surfaces, and Expectations of FDA and EMA Process Validation Guidance Documents. February 18-19, 2015, in San Juan, Puerto Rico.

            12. "Applying Cleaning Validation Principles in the Manufacture of Medical Devices and Diagnostics" and "Issues in Setting Health-based Limits for Actives and Cleaning Agents", presented at IVT Cleaning Validation Conference, August 20, 2014, San Diego, CA.

            13. A two-day advanced topics traning entitled "Cleaning Validation and Shared Facilities" was presented under the auspices of the Israel PDA Chapter. November 12-13, Ramat Gan, Israel.

            14. "Establish Appropriate Residue Limits for Actives in Drug Product Manufacture" and "Establish and Validate Dirty and Clean Hold Times," presented at IVT Cleaning Validation COnference, August 21-22, 2013, San Diego, CA.

            15. "Microbiological Issues in Process Equipment Cleaning Validation", presented at PMF Microbial Control Conference, Key Largo, FL, February 23, 2010 and Key West, January 26, 2011.

              16. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", "Sampling Methods", and "Microbial Control Issues", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV (October 2006, February 2007, October 2007, May 2008, December 2008).

                17. "Cleaning Validation", presented at FDA Pharmaceutical Inspections for Analysts, FDA, Rockville, MD, July 17, 2008.

                  18. "Cleaning Validation for API Manufacture", presented at "CGMP Compliance Conference for Pharmaceutical Ingredients", sponsored by Synthetic Organic Chemical Manufacturers Association, Washington D.C., September 6, 2007.

                    19. "Dealing With Myths of Cleaning Validation", "Grouping Strategies for Cleaning Validation", and "Revalidation Practices", presented at Optimizing Cleaning and Disinfectant Validation conference, sponsored by ISPE Nordic, Copenhagen, Denmark, May18, 2007.

                      20. "Dealing With Myths of Cleaning Validation", "Grouping Strategies for Cleaning Validation", and "Revalidation Practices", presented at Special Topics Seminar, sponsored by STERIS Corporation, Hamburg, Germany, May17, 2007.

                        21. "Cleaning Validation: Advanced Topics", sponsored by Echo Consulting Group, San Juan, PR, May30-31, 2006.

                          22. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, February 16-17, 2006.

                            23. "Applying FMEA (Failure Mode and Effect Analysis) to Cleaning Processes", "Product Grouping Strategies for Cleaning Validation", "Dealing with Extraneous Peaks in Analytical Methods for Cleaning Validation Protocols", "Issues in Cleaning Validation Swab Recovery Studies", "Utilizing TOC as an Analytical Method for Residue Measurements", presented at PharmaConference's "Cleaning Validation: Taking It to the Next Level", in Las Vegas, NV, January 26-27, 2006.

                              24. "Microbial Control Issues in Cleaning Validation for Oral Solid Products", Consultancy Forum for Pharmaceutical Engineers, Cork, Ireland, November 16, 2005.

                                25. "Cleaning Validation Issues for Primary Packaging Equipment", Consultancy Forum for Pharmaceutical Engineers, Dublin, Ireland, November 15, 2005.

                                  26. "Cleaning Validation: Laboratory Course", PDA TRI, Baltimore/Bethesda, presented several times 2005-2008.

                                    27. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, October 10-11, 2005.

                                      28. Impact of New FDA Inspection Program on Cleaning Validation", "Process Analytical Technologies (PAT) for Validated Cleaning Processes", "Strategies for Cleaning and Documentation of Effectiveness Following Interventions", "Issues in Designing and Validating Manual Cleaning Processes", "Worst-Case Challenges to a Cleaning Process in a Validation Protocol", "Design of Clean Hold Time Protocols", and "Appropriate Limit Setting and Recovery Studies for Rinse Sampling", presented at PharmaConference's FDA Current In-Depth Cleaning Validation Issues, presented May 16-17, 2005 in Philadelphia; June 6-7, 2005 in San Juan; September 29-30, 2005 in Dublin; and October 3-4, 2005 in Berlin.

                                        29. I co-taught the course "Cleaning Validation: Laboratory Course", PDA TRI, Baltimore, May 7-9, 2005.

                                          30. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, February 8-9, 2005.

                                            31. "Measuring Bioburden for Cleaning Validation Protocols", "Residue Limits for Cleaning Validation" (workshop), "Sampling Methods and Sampling Recoveries" (workshop), A3P Canada Technical Conference, Quebec City, Canada, November 23-24, 2004.

                                              32. "PAT for More Efficient Cleaning Processes", "Establishing Residue Limits for Cleaning Validation" (workshop), "Sampling Methods and Sampling Recoveries" (workshop), presented at IVT's Cleaning Validation & Critical Cleaning Processes, Amsterdam, The Netherlands, November 15-17, 2004.

                                                33. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, November 9-10, 2004.

                                                  34. "Selecting and Using Appropriate Swab and Rinse sampling Techniques", "Establishing Worst-case Challenges for a Cleaning Validation Protocol", "Setting Scientifically-based and Achievable Residue Limits", "Selecting Appropriate Analytical Techniques for Measuring Residues", presented at PharmaConference's Cleaning and Cleaning Validation for CIP Systems, Munich, Germany, October 27, 2004.

                                                    35. "Impact of the New FDA Inspection Program on Cleaning Validation", "PAT for Validated Cleaning Processes", presented at PharmaConference's FDA and the Current Challenge of GMPs, Munich, Germany, October 25-26, 2004.

                                                      36. "Impact of New FDA Inspection Program on Cleaning Validation", "Process Analytical Technologies (PAT) for Validated Cleaning Processes", "Strategies for Cleaning and Documentation of Effectiveness Following Interventions", "Issues in Designing and Validating Manual Cleaning Processes", "Worst-Case Challenges to a Cleaning Process in a Validation Protocol", "Design of Clean Hold Time Protocols", and "Appropriate Limit Setting and Recovery Studies for Rinse Sampling", presented at PharmaConference's Current In-Depth Cleaning Validation Issues, Chicago, IL, September 20-21, 2004.

                                                        37. "Current Trends in Pharmaceutical and Biotech Cleaning Validation Technology", PMC Teleconference, May 13, 2004.

                                                          38. "Cleaning Validation for Medical Device Manufacture", one-day seminar sponsored by Cleaning Validation Technologies, presented 2 times (2004).

                                                            39. "Current Issues in Cleaning Validation", More Current GMPs for the Pharmaceutical Industry, New Orleans, LA, May 26, 2004.

                                                              40. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, May 22-23, 2004.

                                                                41. "Analytical Lab Issues in Cleaning Validation", FDA CDER Current Good Manufacturing Practice Seminar Series, Rockville, MD, February 25, 2004.

                                                                  42. "Cleaning Validation for Cosmetics Manufacture", CTFA Microbiology Seminar, Newark, NJ, October 16, 2003.

                                                                    43. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, May 10-11, 2003.

                                                                      44. "Dispelling the Myths of Cleaning Validation", PDA Capital Chapter Meeting, Gaithersburg, MD, October 30, 2002.

                                                                        45. "Setting Residue Limits", IIR Cleaning Validation Conference, Philadelphia, PA July 30, 2002

                                                                          46. "Establishing Residue Acceptance Criteria", Barnett International Cleaning and Cleaning Validation Conference, Philadelphia, PA, June 28, 2002.

                                                                            47. "Introduction to CV and Regulations", "Master Plans and Protocols", "Residues and Acceptance Limits", "Analytical Method Overview", "TOC and its Applicability to CV", and Sampling Methods and Recovery", presented at Ionics Cleaning Validation Development and Implementation, Boulder, CO, May 7-8, 2002.

                                                                              48. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, May 18-19, 2002.

                                                                                49. Residue Limits for Cleaning Agents Used in Pharmaceutical Manufacturing, Society of Chemical Engineers Japan (SCEJ), Osaka, Japan, February 7, 2002.

                                                                                  50. Cleaning Validation Residue Limits for Non-Uniform Contamination, PDA Annual Meeting, Washington, DC, December 4, 2001.

                                                                                    51. "Cleaning Validation and Verification for a Traditional Pharmaceutical Facility", presented at AAI Process Validation Conference, San Francisco, CA, September 11, 2001.

                                                                                      52. "Cleaning Cycle Development", "Setting Residue Limits", and "Analytical Technique Selection", presented at IIR Cleaning Validation Conference, Philadelphia, PA October 11-12, 2001.

                                                                                        53. "Overview of Cleaning Validation", "Regulatory Background for Cleaning Validation", "Cleaning Agents", "Setting Residue Limits", and "Sampling Methods", presented at University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Durham, NC, October 22-23, 2001.

                                                                                          54. Validation Maintenance: Staying in Compliance, IIR Cleaning Validation Conference, San Francisco, CA, August 6, 2001.

                                                                                            55. From Cleaning to Cleaning Validation: Development to Launch (2 workshops), GMP by the Sea, Hilton Head Island, SC, August 28, 2001.

                                                                                              56. Validation Maintenance: Staying in Compliance, IVT Cleaning Validation Conference, London, England, May 21, 2001.

                                                                                                57. Validation Maintenance: Staying in Compliance, IVT Cleaning Validation Conference, Washington, DC, May 23, 2001.

                                                                                                  58. Overview of Cleaning Validation, Regulatory Background for Cleaning Validation, Cleaning Agents, Setting Residue Limits, and Sampling Methods, University of Wisconsin's Cleaning Validation Practices for Pharmaceutical Manufacture, Las Vegas, NV, May 20-21, 2001.

                                                                                                    59. Microbial Aspects of Process Cleaning Validation, PDA Spring Meeting, Las Vegas, NV, May 13, 2001.

                                                                                                      60."'Visually Clean' as a Sole Acceptance Criterion for Cleaning Validation Protocols", PDA Japan Congress 2001, Kyoto, Japan, February 21, 2001.

                                                                                                        61. "Establishing Residue Acceptance Criteria", Barnett International Cleaning and Cleaning Validation Conference, Philadelphia, PA, February 2, 2001.

                                                                                                          62. "Visually Clean as a Sole Acceptance Criteria for Cleaning Validation Protocols", PDA Annual Meeting, Philadelphia, PA, December 6, 2000.

                                                                                                            63. "Cleaning Agents for Validated Manufacturing Processes", AOAC Section Meeting on Cleaning Technology and Validation, Wilmington, DE, October 17, 2000.

                                                                                                              64. "Analytical Strategies for Chemical Residues for Cleaning Validation", PDA Conference on The Future of Validation, Milan, Italy, October 11, 2000.

                                                                                                                65. "Cleaning Validation for Lyophilizers", ISPE Lyophilization: Theory and Practice Conference, Zurich, Switzerland, September 20-21.

                                                                                                                  66. "Cleaning Validation Issues for Freeze Dryers", ISPE Cleaning and Cleaning Validation Conference, Zurich, Switzerland, September 18-19, 2000.

                                                                                                                    67. "Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of APIs", 15th ICCCS International Symposium and 31st R3-Nordic Symposium on Contamination Control. Copenhagen, Denmark, May 17, 2000.

                                                                                                                      68. "Setting Residue Limits for Drug Products and APIs", IVT Second Annual Cleaning Validation Conference, Philadelphia, PA, May 10-11, 2000.

                                                                                                                        69. "Cleaning Agents", "Process/Engineering Aspects of Cleaning", "Setting Residue Limits", and "Sampling Methods", Univ. of Wisconsin Cleaning Validation 2000 Conference, Las Vegas, NV, May 20-21, 2000.

                                                                                                                          70. "Cleaning Validation for Freeze Dryers", PDA Annual Meeting, Washington, DC, December 3, 1999.

                                                                                                                            71. "Validating Your Cleaning Agent: Best Practices in the Real World", IIR Sixth Annual Cleaning Validation Conference, Princeton NJ, October 27-29, 1999.

                                                                                                                              72. "Cleaning Agents: Their Role and Choosing the Best One", IVT First International Conference on Cleaning Validation, Princeton, NJ, May 12-13, 1999.

                                                                                                                                73. "Cleaning Technologies", "Process Issues in Cleaning", "Cycle Development", "Residues and Limits", and "Sampling", Univ. of Wisconsin Cleaning Validation Practices for Pharmaceutical Production, Durham, NC, May 15-16, 1999.

                                                                                                                                  74. "Validating your cleaning agent: Best practices in the real world", IIR Fifth Annual Cleaning Validation Conference, Princeton NJ, October 19-21, 1998.

                                                                                                                                    75. "Cleaning Validation: The Rationale Behind Detergent Selection and Optimization", A3P Congress, Archachon, France, October 14-16, 1998.

                                                                                                                                      76. "Residue Analysis and Cleaning Limits", AAI Cleaning Validation in the Pharmaceutical Industry: A 1998 Update, Chicago, IL, June 4, 1998.

                                                                                                                                        77. "Residue Analysis and the Development of Cleaning Limits", AAPS Workshop on Analytical Validation, Arlington, VA, May 7, 1998.

                                                                                                                                          78. "Qualification of Cleaning Procedures for Clinical Manufacturing and Packaging", IMDG, New Brunswick, NJ, June 10, 1997.

                                                                                                                                            79. "Cleaning and Cleaning Validation for Glassware Washers", On-site half-day Seminar, Chicago, IL, February 14, 1997.

                                                                                                                                              80. "Plant Environment: Validation of Cleaning Systems", CTFA, Edison NJ, November 20, 1996.

                                                                                                                                                81. "Chemical Control of Microorganisms in Lab Animal Facilities", AALAS-NCNB, Baltimore, MD, September 18, 1996.

                                                                                                                                                  82. "Process Considerations in the Cleaning of Pharmaceutical Manufacturing Equipment", ISPE San Diego Chapter, San Diego CA, February 1, 1996.

                                                                                                                                                    83. "The Science of Cleaning", AAPS Annual Meeting, San Antonio TX, November 15-19, 1992.