Michael J. Miller, Ph.D.
`
`
`
`Experience
`
`Microbiology Consultants, LLC, Lutz, Florida
`President
`February 2009 to present
`
`Provide regulatory, quality and compliance solutions for the pharmaceutical, biotech, medical device and other
`regulated industries. Develop microbiological monitoring, control and continuous improvement strategies for API
`and fill-finish manufacturing, fermentation, recovery and purification, and aseptic processing and non-sterile
`manufacturing. Design and administer microbiological programs including environmental monitoring,
`investigations of laboratory and manufacturing microbial excursions and out-of-specification findings, laboratory
`audits, optimization and management, laboratory and facility design and qualification, cGMP compliance,
`Pharmacopoeial compliance, barrier isolator design and microbiological validation, microbiology method and
`protocol development, validation and technology transfer, contact lens care formulation development,
`manufacturing, stability testing and product release, disinfection, sterilization and the use of biological indicators,
`cleaning validation, process development, regulatory audit response (e.g., FDA 483 and warning letters), regulatory
`dossier development support, and Process Analytical Technology (PAT). Support microbiology and rapid
`microbiological method suppliers and industry end-users in developing next generation technology platforms,
`validation and testing plans, financial and return on investment (ROI) strategies, commercialization approaches, and
`global regulatory and pharmacopoeia compliance. Act as subject matter expert for microbiology technology
`companies during due diligence, partnership, collaboration, merger and acquisition activities. Expert witness for
`matters related to pharmaceutical microbiology, contamination control, antimicrobial and preservative effectiveness,
`sterilization, pharmacopoeia interpretation and compliance, laboratory and manufacturing GMPs, formulation
`development and stability, sterile and nonsterile manufacturing, research and development, and product quality.
`
`
`Eli Lilly and Company, Indianapolis, Indiana
`Director, Microbiology Leader and Senior Research Fellow
`Manufacturing Science and Technology
`October 2003 to February 2009
`
`Provide technical and strategic leadership for microbiology and across all Manufacturing networks (Parenteral,
`Drug Product, Small and Large Molecule Bulk API) and in Product Research & Development. Support the
`development and technology transfer of new molecules and processes while aligning these activities with Lilly's
`Single Process Map, Quality by Design (QbD) and World Class Commercialization programs. Partner with Quality,
`Engineering, Operations and Development to ensure that the company meets or exceeds industry standards and
`regulatory expectations from a microbiological and sterility assurance perspective. Focus on the interface between
`Manufacturing and Development as microbiological control strategies are defined for new products, production
`facilities and contract manufacturers. Champion efforts to assess and implement new technologies and corporate
`manufacturing strategies that are aligned with GMPs for the 21st Century and Quality by Design (QbD) initiatives,
`including PAT applications, rapid microbiological methods and barrier isolator manufacturing platforms. Partner
`with Global Quality Control Laboratory Microbiology Validation function to develop and implement next
`generation QC microbiology in-process bioburden, raw material, finished product and environmental monitoring
`platforms. Develop and maintain highly capable and dedicated PAT staff comprised of Ph.D. Research Scientists,
`Analytical Chemists and Technical Associates, maintain function's annual budget, and conduct performance
`appraisals. Guide subordinates in carrying out responsibilities and provide adequate resources to ensure that the
`PAT function is capable of supporting the network's goals and objectives. Influence changes to microbiology,
`sterility assurance and PAT industry best practices through external interactions with professional and international
`compendial organizations. Interface with the FDA PAT team, CDER compliance and review microbiology staff and
`international regulatory authorities to influence change to future dossier/submission expectations and a reduction of
`regulatory review requirements that are aligned with Lilly's long-term product development and manufacturing
`strategies.
`
`
`
`1
`
`

`

`M.J. Miller, Page 2 of 16
`
`
`
`Pharmaceutical Systems, Inc., Mundelein, Illinois
`Vice President, Consulting
`February 2002 to September 2003
`
`Responsible for consulting, developing and implementing pharmaceutical manufacturing, QA/QC and regulatory
`solutions in all areas of medical device and pharmaceutical operations including sterilization, aseptic and non-sterile
`compounding and filling, Research & Development, microbiology, environmental monitoring, isolator/barrier
`systems, GMP/QSR compliance, QA/QC, regulatory submissions, manufacturing and laboratory start-up operations
`and regulatory compliance. Directly manage the activities for more than 20 consultants at a major pharmaceutical
`manufacturing facility under consent decree.
`
`
`Bausch & Lomb, Rochester, New York
`Director, External Technology
`Global Vision Care
`October 2000 to January 2002
`
`Identify external commercialization, new product development, joint-ventures, licensing and acquisition
`opportunities that are consistent with the strategic direction within Bausch & Lomb's Vision Care, Pharmaceutical,
`Surgical, General Eye Care and Vision Accessories business units. Interact directly with the company's Global
`Category Leaders, Corporate Business Development and Legal, and the commercial functions within each business
`unit. Represent the Company in negotiations and leverage its position with external clients and other companies via
`business initiatives and acquisitions and alliances. Coordinate technical due diligence activities within the Research
`& Development, Engineering and Commercialization/Marketing organizations. Act as United States Delegate on
`ISO Technical Committee 172; Optics and Ophthalmics.
`
`
`Bausch & Lomb, Rochester, New York
`Director, Biological and Sterilization Sciences
`Global Vision Care
`January 1997 to September 2000
`
`Lead Global Microbiology, Toxicology and Sterilization Core Competencies supporting Bausch & Lomb's Vision
`Care, Pharmaceutical and Surgical Divisions worldwide. Support R&D new product development management
`process (contact lens, lens care, general eye care, ophthalmic pharmaceuticals, surgical devices), new product
`strategic direction, global product stability, and on-site product performance (e.g., with LASIK surgeons). Direct all
`microbiological and toxicological pre-clinical testing for Vision Care Division. Support global Operations (product
`release, process improvements, validation, training, laboratory start-up, troubleshooting), New Product Business
`Development (technical due diligence), Marketing (product claims, publications, professional meeting
`presentations) and Quality (internal and external lab and manufacturing audits/issues, ISO certification, domestic
`and International Quality Systems; ISO 9001, EN 46001, GMP). Support Regulatory Affairs (510k, PMA, CE
`submissions, product returns, field issues), and Legal (patent support, product litigation, competitive claims).
`Identify and evaluate external technologies, research collaborations, and products and processes that are consistent
`with the Corporation's long-term vision. Technical support during ISO and FDA audits. Maintain financial
`accountability for the function. Serve as Corporate liaison for ISO/AAMI Sterilization Standards Committees and a
`United States Delegate on ISO Technical Committee 172; Optics and Ophthalmics.
`
`
`Bausch & Lomb, Rochester, New York
`Manager, Research Microbiology
`Global Vision Care
`March 1994 to December 1996
`
`Direct Senior Scientist staff in support of Global Research & Development for Contact Lens Care, General Eye
`Care, Device and Health Care sectors. Project Manager for Disinfection Research, High Throughput Screening Core
`Technologies and other product development management teams. Provide support for domestic (510k, PMA) and
`International registration of Contact Lens and General Eye Care products. Start-up, audit (cGMP/ISO) and certify
`analytical laboratories and manufacturing sites worldwide. Primary Microbiology contact during FDA on-site, pre-
`
`2
`
`

`

`M.J. Miller, Page 3 of 16
`
`
`approval and GMP inspections. Direct terminal sterilization validation studies for medical device sector. Corporate
`consultant for on-site global Microbiology issues (manufacturing, aseptic processing, sterilization, process
`improvements, regulatory and GMP compliance, environmental monitoring, marketing). Microbiology Core
`Technology for container/closure and preservative-free multi-dose delivery systems. Corporate liaison for ISO/TC
`198 (Sterilization of Health Care Products), U.S. delegate for ISO/TC 172 (Contact Lenses; U.S. Expert for
`Microbiology Committee), ANSI, and FDA standards development committees. Manage cost/budgets for laboratory
`and product development projects. Manage radioisotope testing facility. Certified ISO 9000 auditor for Division.
`
`
`Bausch & Lomb, Rochester, New York
`Manager, Quality Assurance Microbiology
`Personal Products Division
`August 1991 to February 1994
`
`Direct exempt and non-exempt scientists and technicians. Support Corporate manufacturing and engineering units
`(contamination control, environmental monitoring, terminal sterilization validations). Direct release and stability
`testing of devices and aseptically filled products for Personal Products, Contact Lens and Pharmaceutical Divisions
`worldwide. Review laboratory compliance issues; modify existing and create new systems to comply with current
`GMPs and International compendial guidelines. Responsible for personnel training and start-up of Microbiology
`analytical laboratories and manufacturing sites. Audit and certify contract laboratories. Supervise barrier technology
`sterility test workstation and vaporized hydrogen peroxide bio-decontamination system. Coordinate consumer
`affairs microbiology testing. Act as consultant on quality issues, troubleshooting, and standards review and
`development. Primary Microbiology contact during FDA on-site, pre-approval inspections. Represent Corporation
`on AAMI - ISO Technical Committee 198 - Sterilization of Health Care Products.
`
`
`Johnson & Johnson Medical, Inc., Arlington, Texas
`Manager, Senior Microbiologist
`Research & Development
`July 1988 to July 1991
`
`Direct personnel in support of new product development for emerging hospital sterilization technologies
`(STERRAD peroxide/plasma system). Develop process validations for medical device sterilization. Interact with
`hospital administration and central supply during clinical trials of new sterilization technologies. Provide
`documentation of analytical test procedures, corresponding data and interpretations for FDA 510(k) submissions.
`Support the development of pre-clinical studies for advanced wound care products.
`
`Education
`
`Ph.D. Microbiology and Biochemistry. Georgia State University, Atlanta, Georgia, 1988
`Doctoral Dissertation: Adherence of Pseudomonas aeruginosa to Contact Lenses.
`
`B.A. Anthropology and Sociology (double major). Chemistry (minor). Hobart College, Geneva, New York, 1983
`
`Awards and Honoraria
`
`John Henry Hobart Fellow in Residence for Ethics and Social Change, Hobart and William Smith Colleges
`2008
`2006 Distinguished Service Award, Parenteral Drug Association (PDA)
`2006 Microbiologist of the Year, Institute for Validation Technology (IVT)
`
`Academic Affiliations
`
`Adjunct Professor, Department of Biology, Georgia State University, Atlanta GA (current)
`Adjunct Professor, School of Optometry, University of Waterloo, Ontario, Canada (past)
`Alumni Council, Hobart College, Geneva, NY (current)
`
`
`3
`
`

`

`M.J. Miller, Page 4 of 16
`
`
`
`Editorial Review and Advisory Boards (current)
`
`American Pharmaceutical Review
`European Pharmaceutical Review
`PDA Journal of Science and Technology
`
`Professional Memberships and Appointments (current)
`
`Parenteral Drug Association (PDA)
` Chair, Technical Report #33 Task Force
` Technical Book Advisory Board
`International Society for Pharmaceutical Engineering (ISPE)
`American Society for Microbiology (ASM)
`
`Professional Memberships and Appointments (past)
`
`PDA Strategic Planning Committee and Annual Meeting Program Committee
`PDA Program Advisory Board
`Co-chair, PDA 1st and 3rd Annual Global Conference on Pharmaceutical Microbiology
`Contact Lens Association of Ophthalmologists (CLAO)
`Contact Lens Institute (CLI)
`British Contact Lens Association (BCLA)
`American Association of Optometry (AAO)
`Association for Research in Vision and Ophthalmology (ARVO)
`United States Delegate, ISO Technical Committee 172, Optics and Ophthalmics
`Committee member, Association for the Advancement of Medical Instrumentation (AAMI)
`Committee member, American National Standards Institute (ANSI), Z80 Ophthalmics
`ISO Technical Committee 198, Sterilization of Health Care Products
`Chairperson, USP Technical Committee 18, Working Group 6 (Rapid Microbiological Methods)
`
`Expert Witness, Deposition and Trial Testimony
`
`2013. Peter Robertson and Kindra Robertson v. McNeil-PPC, Inc. and Johnson & Johnson, and DOES 1. Case No.
`2:11-cv-09050-JAK-SS.
`
`2009-2012. Astrazeneca LP and Astrazeneca AB v. Apotex, Inc. and Apotex Corp. Civil Action File No. 1:09-CV-
`1518 (RMB) (AMD) consolidated into Civil Action No.: 1:08-CV-1512.
`
`2011. Alcon Research, Ltd. v. Barr Laboratories, Inc., Par Pharmaceutical, Inc. Civil Action No. 09-318-LDD
`(Consolidated).
`
`2009-2010. Aletia Moon and James Zachary Carrier v. Advanced Medical Optics, Inc. Civil Action File No. 4:08-
`CV-021-HLM.
`
`Publications, Books and Book Chapters
`
`2013 Miller, M.J. An Introduction to Rapid Microbiological Methods: Regulatory Acceptance, Validation and
`Implementation. BioPharma Asia. 2(3): in print.
`
`
`2013 Miller, M.J. The Encyclopedia of Rapid Microbiological Methods: The New Fourth Volume Discusses
`Technologies, Regulatory Acceptance and Validation Case Studies. European Pharmaceutical Review.
`18(3): in print.
`
`
`2013 Miller, M.J. Framework for Fast Microbiological Assessment. Pharmaceutical Manufacturing. 12(3): 39-
`41.
`
`
`
`4
`
`

`

`2013 Miller, M.J. Looking to the Future: Rapid and Automated Microbial Identification Technologies, in
`Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis
`Healthcare International Publishing.
`
`M.J. Miller, Page 5 of 16
`
`
`
`
`2013 Miller, M.J.; Walsh, M.R.; Shrake, J.L.; Dukes, R.E.; Hill, D.B. Evaluation of the BioVigilant IMD-A, a
`novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable
`and nonviable particles. Part II: Case studies in environmental monitoring during aseptic filling,
`intervention assessments and glove integrity testing in manufacturing isolators, in Encyclopedia of Rapid
`Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis Healthcare International
`Publishing.
`
`
`2013 Miller, M.J.; Lindsay, H.; Valverde-Ventura, R.; O’Connor, M.J. Evaluation of the BioVigilant IMD-A, a
`novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable
`and nonviable particles. Part I: Review of the technology and comparative studies with conventional
`methods., in Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller.
`PDA and Davis Healthcare International Publishing.
`
`
`2013
`
`Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis
`Healthcare International Publishing.
`
`
`2013 Miller, M.J., Fragoeiro, S., Ramachandran, A., van Empel, P. Improving the Quantitation of Live Antigens
`used to produce Rabbit Generated Serotype Specific Aniserum. European Pharmaceutical Review. 18(1):
`55-57.
`
`
`2012 Miller, M.J.: Hot Topics in Rapid Methods: Revisions to Validation Guidance and Real-Time
`Environmental Monitoring. European Pharmaceutical Review. 17(6): 58-61.
`
`
`2012 Miller, M.J. Looking to the Future: Rapid and Automated Microbial Identification Technologies, in
`Microbial Identification. The Keys to a Successful Program. Edited by Mary Griffin and Dona Reber, PDA
`and Davis Healthcare International Publishing. Chapter 15: 1-29.
`
`
`2012 Miller, M.J.; Miyashita, N. Rapid Micro Methods and the Next Generation in ATP Bioluminescence.
`European Pharmaceutical Review. 17(5): 14-16.
`
`
`2012 Miller, M.J. Opportunities for Rapid Methods Discussions: Where the Experts are Meeting! European
`Pharmaceutical Review. 17(4): 11-13.
`
`
`2012 Miller, M.J. Rapid Sterility Testing and the Impact of Recent Changes to the US Code of Federal
`Regulations. European Pharmaceutical Review. 17(3): 65-67.
`
`
`2012 Miller, M.J. Rapid Micro Methods and EMA’s Post Approval Change Management Protocol. European
`Pharmaceutical Review. 17(2): 65-67.
`
`
`2012 Miller, M.J. Case Study of a New Growth-Based Rapid Microbiological Method (RMM) that Detects the
`Presence of Specific Organisms and Provides an Estimation of Viable Cell Count. American
`Pharmaceutical Review. 15(2): 18-25.
`
`
`2012 Miller, M.J. Rapid Micro Methods: New Year, Old Challenges! European Pharmaceutical Review. 17(1):
`8-11.
`
`
`2011 Miller, M.J. Detection of Microorganisms Using Micro-Electro-Mechanical Systems (MEMS). European
`Pharmaceutical Review. 16(6): 7-10.
`
`
`2011 Miller, M.J. Detection of Microorganisms Using Nucleic Acid and Gene Amplification-Based Rapid
`Method Technologies. European Pharmaceutical Review. 16(5): 62-65.
`
`
`2011 Miller, M.J. Detection of Microorganisms Using Optical Spectroscopic-Based Rapid Method
`
`5
`
`

`

`Technologies. European Pharmaceutical Review. 16(4): 40-42.
`
`M.J. Miller, Page 6 of 16
`
`
`
`
`2011 Miller, M.J. Detection of Microorganisms Using Cellular Component-Based Rapid Method Technologies.
`European Pharmaceutical Review. 16(3): 8-10.
`
`
`2011 Miller, M.J. QbD, PAT, and the Future of Microbiology. Environmental monitoring with RMM. Contract
`Pharma. 13(4): 70-73.
`
`
`2011 Miller, M.J. Direct Detection of Microorganisms Using Viability-Based Technologies. European
`Pharmaceutical Review. 16(2): 14-15.
`
`
`2011 Miller, M.J. Rapid Microbiological Methods 2011. A Review of Growth-Based Technologies. European
`Pharmaceutical Review. 16(1): 38-41.
`
`
`2011 Miller, M.J. The Implementation of Rapid Microbiological Methods, in Microbiology and Sterility
`Assurance in Pharmaceuticals and Medical Devices. Edited by Madhu Raju Saghee, Tim Sandle and
`Edward C. Tidswell, Business Horizons.
`
`
`2010 Miller, M.J. Microbiology Series. Article 6: The Implementation of Rapid Microbiological Methods.
`European Pharmaceutical Review. 15 (6), 27-31.
`
`
`2010 Miller, M.J. Microbiology Series. Article 5: The Implementation of Rapid Microbiological Methods.
`European Pharmaceutical Review. 15 (5), 9-11.
`
`
`2010 Miller, M.J. Microbiology Series. Article 4: The Implementation of Rapid Microbiological Methods.
`European Pharmaceutical Review. 15 (4), 17-19.
`
`
`2010 Miller, M.J. Microbiology Series. Article 3: The Implementation of Rapid Microbiological Methods.
`European Pharmaceutical Review. 15 (3), 18-21.
`
`
`2010 Miller, M.J. Developing a validation strategy for rapid microbiological methods. American Pharmaceutical
`Review. 13 (3), 28-33.
`
`
`2010 Miller, M.J. Microbiology Series. Article 2: The Implementation of Rapid Microbiological Methods.
`European Pharmaceutical Review. 15 (2), 24-26.
`
`
`2010 Miller, M.J. Microbiology Series. Article 1: The Implementation of Rapid Microbiological Methods.
`European Pharmaceutical Review. 15 (1), 39-41.
`
`
`2010 Miller, M.J.; Moldenhauer, J. Revision of PDA Technical Report Number 33. American Pharmaceutical
`Review. 13 (1), 86-91.
`
`
`2009 Miller, M.J. Breaking the Rapid Microbiological Method Financial Barrier: A Case Study in RMM Return
`on Investment and Economic Justification. BioPharm International. 22 (9), 44-53.
`
`
`2009 Miller, M.J. Evaluation of the BioVigilant IMD-A, a Novel Optical Spectroscopy Technology for the
`Continuous and Real-Time Environmental Monitoring of Viable and Nonviable Particles,
`in
`Environmental Monitoring, Volume 3. Edited by Jeanne Moldenhauer, PDA and Davis Healthcare
`International Publishing. 269-288.
`
`
`2009 Miller, M.J. Rapid microbiological methods and demonstrating a return on investment: It’s Easier than you
`think! American Pharmaceutical Review. 12 (5), 42-47.
`
`
`2009 Miller, M.J. Real-time environmental monitoring: PAT solutions using rapid microbiological methods.
`European Pharmaceutical Review. 14 (4), 40-46.
`
`
`2009 Miller, M.J. Ensuring ROI from your RMM. Pharmaceutical Manufacturing. 8 (6), 32-35.
`
`6
`
`

`

`
`2009 Miller, M.J.; Lindsay, H.; Valverde-Ventura, R.; O’Connor, M.J. Evaluation of the BioVigilant IMD-A, a
`novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable
`and nonviable particles. Part I: Review of the technology and comparative studies with conventional
`methods. PDA J. Pharm. Sci. Technol. 63 (3), 244 –257.
`
`M.J. Miller, Page 7 of 16
`
`
`
`
`2009 Miller, M.J.; Walsh, M.R.; Shrake, J.L.; Dukes, R.E.; Hill, D.B. Evaluation of the BioVigilant IMD-A, a
`novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable
`and nonviable particles. Part II: Case studies in environmental monitoring during aseptic filling,
`intervention assessments and glove integrity testing in manufacturing isolators. PDA J. Pharm. Sci.
`Technol. 63 (3), 258 –282.
`
`
`2009 Miller, M.J. Quality risk management and the economics of implementing rapid microbiological methods.
`European Pharmaceutical Review. 14 (2), 66-73.
`
`
`2009 Miller, M.J. It’s Time to Get Rapid! PDA Letter. April; 45 (4): 1-21.
`
`2009 Miller, M.J. Rapid Microbiological Methods in Support of Aseptic Processing, in Practical Aseptic
`Processing: Fill and Finish Volume 2. Edited by Jack Lysfjord, PDA and Davis Healthcare International
`Publishing. 169-219.
`
`
`2008 Miller, M.J. Rapid Microbiological Methods, in Microbiology in Pharmaceutical Manufacturing Volume 2,
`2nd Edition. Edited by Richard Prince, PDA and Davis Healthcare International Publishing. 171-221.
`
`
`2008 Miller, M.J.; Claerbout, M.E.; DeMaio, R.A.; et al. Microbiological Control Strategies during the
`in Microbiology
`in Pharmaceutical
`Development of Pharmaceutical Products and Processes,
`Manufacturing Volume 1, 2nd Edition. Edited by Richard Prince, PDA and Davis Healthcare International
`Publishing. 237-280.
`
`
`2006 Miller, M.J. Rapid Microbiological Methods for a New Generation. Pharmaceutical Manufacturing.
`February; 5(2): 14-23.
`
`
`2005
`
`Foreword, Encyclopedia of Rapid Microbiological Methods, Volumes 1-3. Edited by Michael J. Miller,
`PDA and Davis Healthcare International Publishing.
`
`
`2005 Miller, M.J. The Impact of Process Analytical Technology (PAT), cGMPs for the 21st Century and Other
`Regulatory and Compendial Initiatives on the Implementation of Rapid Microbiological Methods, in
`Encyclopedia of Rapid Microbiological Methods, Volume 1. Edited by Michael J. Miller, PDA and Davis
`Healthcare International Publishing.
`
`
`2005 Miller, M.J. Rapid Microbiological Methods and FDA’s Initiatives for Process Analytical Technology and
`Pharmaceutical cGMPs for the 21st Century: A Risk Based-Approach. American Pharmaceutical Review.
`January/February; 8(1): 104-107.
`
`
`2003 Reich, R.; Miller, M.; Patterson, H. Developing a viable environmental monitoring program for nonsterile
`pharmaceutical operations. Pharmaceutical Technology. March 2003.
`
`
`2002
`
`Tchao, R.; McCanna, D.; Miller, M.J. Comparison of contact lens multi-purpose solutions by an in vitro
`sodium fluorescein permeability assay. CLAO J. 28: 151-156.
`
`
`2001 Miller, M.J.; Emerson, R. Auditing the Pharmaceutical Microbiology Laboratory, in Microbiology in
`Pharmaceutical Manufacturing. Edited by Richard Prince, Davis Horwood International Publishing,
`Limited. Pages 647-686.
`
`
`2001 Miller, M.J.; Callahan, D.E.; McGrath, D.; et al. Disinfection Efficacy of Contact Lens Care Solutions
`against Ocular Pathogens. CLAO J. 27: 16-22.
`
`
`
`7
`
`

`

`M.J. Miller, Page 8 of 16
`
`
`2000 Miller, M.J.; Manchester, R.J.; Callahan, D. Antimicrobial activity of ReNu MultiPlus against
`Pseudomonas. Contact Lens Spectrum. 15: 23-30.
`
`
`2000 Miller, M.J.; Manchester, R.J.; Callahan, D. Setting the record straight on ReNu MultiPlus solution.
`Optician. 219: 40-42.
`
`
`1999
`
`Lever, A.M.; Miller, M.J. Comparative antimicrobial efficacy of multi-purpose lens care solutions using
`the FDA’s revised guidance document for industry. CLAO J. 25: 52-56.
`
`
`1995 Miller, M.J. Contact lens disinfectants. In Handbook of Disinfectants and Antiseptics, edited by J. Ascenzi.
`Marcel Dekker, Inc., New York, pp. 83-110.
`
`
`1991 Miller, M.J.; Wilson, L.A.; Ahearn, D.G. Adherence of Pseudomonas aeruginosa to rigid gas-permeable
`contact lenses. Arch. Ophthalmol. 109: 1447-1448.
`
`
`1990 Meridith, T.A.; Aguilar, H.E.; Miller, M.J.; et al. Comparative treatment of experimental Staphylococcus
`epidermidis endophthalmitis. Arch. Ophthalmol. 108: 857-860.
`
`
`1990 Meridith, T.A.; Trabelsi, A.; Miller, M.J.; et al. Spontaneous sterilization in experimental Staphylococcus
`epidermidis endophthalmitis. Invest. Ophthalmol. Vis. Sci. 31: 181-186.
`
`
`1988 Ward, M.A.; Miller; M.J. The microbiology of contact lens wear. Contact Lens Forum.
`
`13(2): 25-29.
`
`1988 Miller, M.J.; Wilson, L.A.; Ahearn, D.G. Effects of protein, mucin, and human tears on adherence of
`Pseudomonas aeruginosa to hydrophilic contact lenses. J. Clin. Microbiol. 26: 513-517.
`
`
`1987 Miller, M.J.; Ahearn, D.G. Adherence of Pseudomonas aeruginosa to hydrophilic contact lenses and other
`substrata. J. Clin. Microbiol. 25: 1392-1397.
`
`
`Oral Presentations
`
`2013 About RMM Validation: Technical Report No. 33. Pharmaceutical Microbiology Conference. PDA
`Europe. Berlin, Germany
`
`
`2013 Rapid Microbiological Methods Training Course. Pharmaceutical Microbiology Conference. PDA Europe.
`Berlin, Germany
`
`
`2012 Real-Time Environmental Monitoring Using Optical Spectroscopy Rapid Methods. Rapid Microbiological
`Methods Conference. European Compliance Academy (ECA). Munich, Germany
`
`
`2012 Rapid Microbiological Methods Training Course: Overview of Technologies, Validation Strategies,
`Regulatory Opportunities and Return on Investment. PDA 7th Annual Global Conference on
`Pharmaceutical Microbiology. PDA, Bethesda, MD
`
`
`2012 Real Time Environmental Monitoring and the Quest for Parametric Release of Aseptically Filled Product.
`PDA 7th Annual Global Conference on Pharmaceutical Microbiology. PDA, Bethesda, MD
`
`
`2012 Rapid Microbiological Methods. Technopath Symposium. Dublin, Ireland
`
`2012 Rapid Microbiological Methods: The Detection, Enumeration and Identification of Microorganisms Using
`Genetic-based Technologies. Tungsten Shield Group. Web Seminar.
`
`
`2012 Rapid Microbiological Methods: The Detection, Enumeration and Identification of Microorganisms Using
`Cellular Component-based Technologies. Tungsten Shield Group. Web Seminar
`
`
`2012 Rapid Microbiological Methods Training Course. BioForum Applied Knowledge Center. Tel Aviv, Israel
`
`8
`
`

`

`
`2012 Rapid Microbiological Methods. Recognizing the Perceived Issues Associated with Regulatory
`Expectations, Validation and ROI. PMF Conference on Alternate and Rapid Microbiological Methods.
`Pharmaceutical Microbiology Forum. Las Vegas, NV
`
`M.J. Miller, Page 9 of 16
`
`
`
`
`2012 Rapid Microbiological Methods: The Detection, Enumeration and Identification of Microorganisms Using
`Viability and Spectroscopic-based Technologies. Tungsten Shield Group. Web Seminar.
`
`
`2012 Case Studies in the Use of Continuous Air Monitoring During Manufacturing Interventions Within an
`Isolator Environment. Microbiology, Endotoxins and RMM Conference. PDA Europe. Berlin, Germany
`
`
`2012
`
`Industry: Tear Down this Wall! Removing the Barriers for RMM Implementation. Microbiology,
`Endotoxins and RMM Conference. PDA Europe. Berlin, Germany
`
`
`2012 Quality Systems for Sterile Products. Microbiology, Endotoxins and RMM Conference. PDA Europe.
`Berlin, Germany
`
`
`2012 Rapid Microbiological Methods Training Course. Microbiology, Endotoxins and RMM Conference. PDA
`Europe. Berlin, Germany
`
`
`2012
`
`The Future of Rapid Molecular and Microbiological Methods: A Review of Technologies, Validation
`Strategies and Regulatory Expectations. Validation of Molecular Biological Methods Conference.
`European Compliance Academy (ECA). Prague, Czech Republic
`
`
`2012 Quality Systems for Sterile Products. Advances in Sterile Products Technologies, Future University
`International Conference on Pharmaceutical Technologies. Cairo, Egypt.
`
`
`2012
`
`Environmental Monitoring. Advances in Sterile Products Technologies, Future University International
`Conference on Pharmaceutical Technologies. Cairo, Egypt.
`
`
`2012 Rapid Microbiological Methods: PAT and Microbiology for Sterile Products Testing and Release.
`Advances in Sterile Products Technologies, Future University International Conference on Pharmaceutical
`Technologies. Cairo, Egypt.
`
`
`2012 Rapid Microbiological Methods: The Detection, Enumeration and Identification of Microorganisms Using
`Growth-based Technologies. Tungsten Shield Group. Web Seminar.
`
`
`2011 Rapid Microbiological Methods Training Course: Overview of Technologies, Validation Strategies,
`Regulatory Opportunities and Return on Investment. PDA 6th Annual Global Conference on
`Pharmaceutical Microbiology. PDA, Washington, DC
`
`
`2011 Debunking the Myth’s Surrounding Rapid Microbiological Methods and Their Impact on Pharmaceutical
`Manufacturing and the Quality of Medicinal Products. PDA 6th Annual Global Conference on
`Pharmaceutical Microbiology. PDA, Washington, DC
`
`
`2011 Developing a Return on Investment Strategy for Rapid Microbiological Methods. Tungsten Shield Group.
`Web Seminar.
`
`
`2011 Validating Rapid Microbiological Methods Understanding USP 1223, Ph. Eur. 5.1.6 and PDA TR#33.
`Tungsten Shield Group. Web Seminar.
`
`
`2011 Navigating the Regulatory Environment When Implementing Rapid Microbiological Methods. Tungsten
`Shield Group. Web Seminar.
`
`
`2011 An Introduction to Rapid Microbiological Methods and the Link to Quality by Design. Tungsten Shield
`Group. Web Seminar.
`
`
`
`9
`
`

`

`2011
`
`
`2011
`
`M.J. Miller, Page 10 of 16
`
`
`The Validation of Rapid Microbiological Methods. A Case Study on False Positive Testing Using
`Manufacturing Test Samples and an Environmental Monitoring Technology. PDA Annual Meeting. PDA,
`San Antonio, TX
`
`The Future of Microbiology – The Impact of Rapid Methods on Pharmaceutical Manufacturing and the
`Quality of Medicinal Products. Pharmaceutical Microbiology – Mycoplasma. Enhancing Quality in Process
`and Product. PDA Europe Conference. Berlin, Germany
`
`
`2011 Validation Summit. Pharmaceutical Microbiology. Quality Academia. Istanbul, Turkey
`
`2010
`
`Pharmaceutical Microbiology for the 21st Century. GMPs, rapid method technologies, regulatory
`expectations and contamination control strategies. Quality Academia. Istanbul, Turkey
`
`
`2010 Rapid Microbiological Methods Training Course. BioForum Applied Knowledge Center. Weizmann
`Science Park, Ness Ziona, Israel
`
`
`2010 Rapid Microbiological Methods Training Course: Overview of Technologies, Validation Strategies,
`Regulatory Opportunities and Return on Investment. PDA 5th Annual Global Conference on
`Pharmaceutical Microbiology. PDA, Washington, DC
`
`
`2010
`
`The Validation of Rapid Microbiological Methods. A Case Study on False Positive Testing Using
`Manufacturing Test Samples and an Environmental Monitoring Technology. PDA 5th Annual Global
`Conference on Pharmaceutical Microbiology. PDA, Washington, DC
`
`
`2010 Rapid Microbiological Methods; an Introductory Review of RMM Technologies, Validation Strategies,
`Applications, Regulatory Expectations, Financial Justification Models & Implementation Plans. Tungsten
`Shield Group. Web Seminar
`
`
`2010 Rapid Molecular and Microbiological Methods: The Link Between Pharmaceutical Manufacturing and
`Quality by Design Principles. Applied Biosystems SEQ