Elite instructors

Agi Denes, Ph.D

Dr. Agi Denes is a highly experienced cosmetic chemist and scientist with over 18 years in the field where she brought to life novel personal care product lines that are at the intersection of science, beauty, and wellness. She has an exceptional interdisciplinary technical expertise across formulations, innovation, technical marketing, claims design and validation, testing… Continue reading Agi Denes, Ph.D

Barry Friedman Ph.D

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department… Continue reading Barry Friedman Ph.D

Beatrice Huey

Ms. Beatrice Huey is currently employed as a Good Tissue Practice Specialist at the University of Arkansas for Medical Sciences in Little Rock, Arkansas. She has more than 20 years’ experience working in FDA-regulated environments and the tissue industry. She has extensive knowledge of current good tissue practice (CGTP), good manufacturing practices (CGMP) and good… Continue reading Beatrice Huey

Bonnie M. Pappacena

Bonnie M. Pappacena is the President, Qualture LLC, a Quality consulting firm committed to building Quality into company culture. Ms. Pappacena has been a Quality professional for over 35 years spanning the animal health, biological, chemical, device, generic, and pharmaceutical industries. She possesses hands-on experience conducting and managing audits in GCP, GLP, GMP (clinical supplies… Continue reading Bonnie M. Pappacena

Burton A. Amernick

Burton A. Amernick is a Senior Partner in the law firm of Polsinelli LLC, a General Practice National AM LAW 100 law firm, where he specializes in patent and trademark causes. In 2020, US News and World Report in their Best Law Firm Listing ranked Polsinelli LLC in Tier One for Patent Law. He was… Continue reading Burton A. Amernick

Charity Ogunsanya

Charity Ogunsanya has more than 30 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of… Continue reading Charity Ogunsanya

Charlie Neal

Charlie Neal, Jr., Owner and Senior Consultant for Premier Quality Consulting, has been in the Pharmaceutical industry for over thirty-five years. He has a wealth of hands-on technical experience acquired from the chemical, drug, device, and pharmaceutical industries. His experience crosses into many areas of these industries including Research, Development, Process Engineering, Validation, Technical Transfers,… Continue reading Charlie Neal

Danielle DeLucy, MS

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 23 years serving in numerous Quality Management Roles, such as the Director of Product… Continue reading Danielle DeLucy, MS

David E. Wiggins

David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer. Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation,… Continue reading David E. Wiggins

David L. Chesney

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC, Cumberland Foreside, Maine. He founded the company in 2016 following 23 years with the FDA and 21 years as Vice President of Strategic Compliance Consulting Services for a major US-based CRO. He began performing GCP inspections for the FDA as early… Continue reading David L. Chesney

David Long

David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône-Poulenc he was Senior Director R&D worldwide for Quality and for Process Improvement. Mr. Long has since worked for… Continue reading David Long

Donna Foster

Donna Foster is a competitive intelligence analyst who has over 14 years of professional experience in the healthcare and consumer product industry. Ms. Foster is a recognized subject matter expert in primary and secondary research in support of product development. As a research & development (R&D) scientist, she has amassed a wide array of specialized… Continue reading Donna Foster

Douglas G. Hayes

Douglas G. Hayes has over 30 years of experience with surfactants and detergents and their use in soft matter systems. Dr. Hayes also has research interests in value-added products from renewable resources, biopolymers in agricultural systems, and nanotechnology. Dr. Hayes has published over 75 publications in peer-reviewed journals, over 20 book chapters, and two co-edited… Continue reading Douglas G. Hayes

Dr. Brad Strahm

Dr. Brad Strahm is a Principal with The XIM Group, LLC, a firm providing consulting services in the area of product development, process engineering, equipment engineering, and project management located in Sabetha, KS. Dr. Strahm holds degrees in Agricultural Engineering from Kansas State University and Business Administration from Kennedy- Western University. Dr. Strahm had 12… Continue reading Dr. Brad Strahm

Dr. Cecil W. Propst

Dr. Cecil W. Propst is Managing Director at Propst Consulting Services, a formulation, and engineering support LLC located in Norton Shores MI. He was Director of R&D (Grand Haven site) at SPI Pharma until 2015. He served as Director of Quality Assurance and Technical Services at Fleming and Company, and before that, President of Manufacturing… Continue reading Dr. Cecil W. Propst

Dr. Ernesto M. Hernandez

Dr. Ernesto Hernandez is currently Principal Consultant with Advanced Lipid Consultants. Formerly Director of Process Development at Omega Protein Inc. and Head of the Fats and Oils Program/ Food Science Faculty at Texas A&M University. His education includes a Ph.D. in Food Engineering from the University of Massachusetts; M.S. in Food Science and Technology from… Continue reading Dr. Ernesto M. Hernandez

Dr. Gregory A. Sacha

Dr. Gregory A. Sacha, is a Senior Research Scientist for Baxter BioPharma Solutions in Bloomington, IN. He received a BS in Pharmacy from Butler University in 1993 and earned a PhD in Industrial and Physical Pharmacy from Purdue University in 1999. Dr. Sacha specializes in the formulation of sterile solutions and lyophilized solids for large… Continue reading Dr. Gregory A. Sacha

Dr. Jayasree (Jay) M. Srinivasan

Dr. Jayasree (Jay) M. Srinivasan is a Research Scientist in the R&D laboratory at Baxter BioPharma Solutions in Bloomington, IN. She received her BSc from University of Madras (India), MS in Synthetic Organic Chemistry from University of Houston, and PhD in Synthetic Organic Chemistry from Indiana University. Her areas of focus at Baxter include formulation… Continue reading Dr. Jayasree (Jay) M. Srinivasan

Dr. Marie-Eve Beaulieu

Dr. Marie-Eve Beaulieu, is Co-founder and Chief Scientific Officer, Peptomyc S.L. Dr. Beaulieu has a strong background in R&D project management and coordinates the scientific team at Peptomyc. Her experience in biochemistry and peptide and protein structure and production enabled her to manage the in-house and outsourced scientific activities at Peptomyc since 2014. Marie-Eve developed… Continue reading Dr. Marie-Eve Beaulieu

Dr. Pardeep K. Gupta

Dr. Pardeep K. Gupta is a Professor of Pharmaceutics in Philadelphia College of Pharmacy at the University of The Sciences in Philadelphia (USciences). He received his B. Pharm. and M. Pharm. (pharmaceutical chemistry) degrees from India. He also received a M.S. degree in medicinal chemistry from USciences and his Ph.D. in pharmaceutics from University of… Continue reading Dr. Pardeep K. Gupta

Edwin Waldbusser

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 12 years. Mr. Waldbusser has a BS in Mechanical Engineering and an… Continue reading Edwin Waldbusser

Eric Abrutryn

Eric Abrutyn is a 1980 graduate of New York University-New Paltz with a Masters in Chemistry and 1970 graduate from C.W. Post College/Long Island University with a B.S. in Chemistry. He has over 51 years of experience in the personal care cosmetics industry. Over that last 12 plus years, Eric has used his consulting firm,… Continue reading Eric Abrutryn

Esther Sadler-Williams

Ms. Sadler-Williams is currently Managing Director, of her own Clinical Supply training and consultancy company – SimplyESW, an organisation that supports clients in enhancing team skills as well as conducting improvement projects to optimise clinical supply chain delivery. Prior to this, Ms. Sadler-Williams was Senior Director of Strategic Alliance Development and Innovation for Catalent Pharma… Continue reading Esther Sadler-Williams

Frank A. Anthony, PhD

Frank A. Anthony, PhD is Owner & President of Consumer Science Solutions, LLC, specializing in Scientific, Clinical, Consumer Science, Claims and Medical Affairs consulting for OTC Products. Frank believes that successful products are the innovative combination of formula + package + claims, requiring a blend of both science and art. He has leveraged his years… Continue reading Frank A. Anthony, PhD

Frank Carroll

Frank Carroll is Director of Supply Chain and Facilities for Zosano Pharma/ZP Group LLC in Fremont CA. He has over 25 years of experience in the Pharmaceutical, Device, Biologics and Biotech industries in many aspects of operations including manufacturing, purchasing, materials management, strategic alliance management, implementation of advanced project management and MRP/ERP systems and senior… Continue reading Frank Carroll

Fred A. Rowley

Fred A Rowley is an internationally recognized expert in solid dosage manufacturing and a pioneer in solid dosage training. He is and has been retained as a subject expert by law firms, equipment manufacturers, international Pharmaceutical and Nutritional Supplement companies and has lectured at the US FDA, the ISPE and at many colleges of Pharmacy… Continue reading Fred A. Rowley

Gail Vance Civille

Gail Vance Civille, President of Sensory Spectrum, Inc., has pioneered advanced sensory evaluation approaches for industry, academia and the government. For over 40 years her application of strategic business initiatives to R&D and marketing projects has impacted sensory science globally. Her fundamental development of flavor, texture, fragrance, Skinfeel and Fabricfeel Spectrum Descriptive Analysis methodology, references… Continue reading Gail Vance Civille

Ginette Collazo, PhD

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. Ten years ago, Dr. Collazo established… Continue reading Ginette Collazo, PhD

Heidi Graham

Ms. Heidi Graham pursued package engineering as a way to blend creativity with science and make a positive impact in people’s lives. Known for her entrepreneurial spirit and bias for action, her work has been recognized for pioneering open innovation and consumer-centric design, including the development of breakthrough continuous spray sunscreen that transformed the category.… Continue reading Heidi Graham

Herberto Dutra

Herberto Dutra, Mechanical Engineer has over 30 years of experience in processing industries with careers at Kraft Foods, Nestle, Bay Valley and Sentient, including 20 years of hands-on experience in Spray Drying. Mr. Dutra’s expertise ranges from pilot plant scaling up, design and construction of numerous Spray Drying plants, day-to-day operation, troubleshooting and optimization. Academically,… Continue reading Herberto Dutra

Irwin Silverstein, Ph.D.

Irwin Silverstein has been a consultant to the pharmaceutical industry since 2000. His career included 17 years as the head of corporate quality for ISP, a specialty chemical manufacturer that produced excipients and Active Pharmaceutical Ingredients. Since leaving ISP, he works as a consultant. He has been a subcontractor to a consulting firm hired as… Continue reading Irwin Silverstein, Ph.D.

J. Jeff Schwegman, Ph.D.

J. Jeff Schwegman, Ph.D. is the founder and chief executive officer of AB BioTechnologies where he manages the day to day operations of the company. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process… Continue reading J. Jeff Schwegman, Ph.D.

J. Mark Wiggins

Mark Wiggins is Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years’ experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck, with more than 15 years’ experience submitting new and revised monographs to pharmacopoeias, as well as reviewing and responding to proposed… Continue reading J. Mark Wiggins

Jan Gates

Jan Gates has 30+ years of experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed… Continue reading Jan Gates

Jennifer R. Martin

Jennifer R. Martin is Director of Regulatory Affairs  North America and Global Skin Health for the Colgate-Palmolive Company and a longtime regulatory affairs and product safety professional. She has more than 30 years of experience in analyzing legislation and regulation and applying it to assure product safety and compliance for cosmetics, drugs, medical devices, foods,… Continue reading Jennifer R. Martin

Jhon Doe

Jhon Doe is a 1985 graduate of New York University-New Paltz with a Masters in Chemistry and 1975 graduate from C.W. Post College/Long Island University with a B.S. in Chemistry. He has over 51 years of experience in the personal care cosmetics industry. Over that last 12 plus years, Eric has used his consulting firm,… Continue reading Jhon Doe

John O’Neill

John O’Neill earned his Bachelor’s degree in Pharmaceutical Sciences from Columbia University and a Master’s in Health Systems Management from Union University. His career of 43 years has taken him from Registered Pharmacist to-Liquids and Semi-solids Formulator at Sterling Winthrop, QC Manager at Sanofi-Aventis, Medical Device Quality Steward at Boston Scientific, Independent Consultant, Principal Stability Specialist… Continue reading John O’Neill

Joseph A. Albanese, Ph.D.

Joe Albanese, Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) where he held positions in R&D, Supply Chain, and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As part… Continue reading Joseph A. Albanese, Ph.D.

Joy Joseph

Joy Joseph is President of Joys Quality Management Systems, a consulting firm serving Dietary Supplement firms through training and implementation of the new cGMPs. She has more than 40 years experience in Quality Control Systems, Regulatory Affairs, Product Development, Manufacturing, and Scientific Affairs in the Pharmaceutical, Dietary Supplement and Cosmetic industries. Ms. Joseph received her… Continue reading Joy Joseph

Joy McElroy

Joy McElroy, has 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies. Ms. McElroy specializes in… Continue reading Joy McElroy

K A Narayanan

K A Narayanan is currently the vice-president, heading the new client initiatives for ACG. He brings to the table a rich experience of 30 years working with over 100 multi-national Pharma and FMCG giants delivering packaging solutions to make their products stand out.

Karl F. Popp, R. Ph.

Karl Popp founded KPopp Consulting, LLC in 2010 as a consulting firm providing services to pharmaceutical, cosmetic and allied industries. He also is a practicing retail pharmacist. During his career he has been responsible for the development of products that have generated over $2 billion in sales. From 1989 to 2008 he was associated with… Continue reading Karl F. Popp, R. Ph.

Khurshid Iqbal, Ph.D.

Dr. Iqbal has over 25 + years of domestic and international experience in pharmaceutical product development. He has worked within the leading multinational pharmaceutical organizations, R.W. Johnson Pharmaceutical Research Institute, Hoffmann-La Roche and E.R. Squibb & Sons and last as Sr. Vice President and CSO at KBI Biopharma, Inc. Dr. Iqbal earned his Ph.D. in… Continue reading Khurshid Iqbal, Ph.D.

Louis Angelucci

Louis Angelucci is a pharmaceutical professional with over 20 years’ experience in Quality Assurance, Quality Control, Regulatory Affairs, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. He has worked for several well-known companies including Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. His experience has… Continue reading Louis Angelucci

Lucia Mokres

Dr. Lucia Mokres is a Biotechnology Entrepreneurial Consultant based in the Bay Area, specializing in helping early stage companies with novel technology gain traction and develop an investable technology and business model, and helping later stage companies work through regulatory and clinical challenges. Prior to establishing her consultancy, she was the Chief Medical Officer of… Continue reading Lucia Mokres

Manuel Gamez-Garcia, Ph.D.

Manuel Gamez-Garcia received his Master’s degree in Electrochemistry from the Tokyo Institute of Technology in Japan, and his PhD in Engineering Physics in the field of Polymers from the Ecole Polytechnique in Montreal, Canada. He worked for two years at the Pirelli Corporation in the field of physical and chemical properties of polymers. Since then… Continue reading Manuel Gamez-Garcia, Ph.D.

Mark Chandler

Mark Chandler is President of ACT Solutions Corp (Adaptive Cosmetic Technology Solutions), a formulation design consultancy founded in 2012, serving the cosmetic and topical pharmaceutical industries, focusing on Adaptive Aesthetic Design, Advanced Emulsion Solutions, and Formulating for Efficacy, with formulation laboratories in Delaware and Ohio. Mr. Chandler has been in the industry for over 30… Continue reading Mark Chandler

Michael Barile

Mr. Barile has over thirty-five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the executive quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and… Continue reading Michael Barile

Mukund Mike Yelvigi

Mukund (Mike) Yelvigi is Principal and Managing Partner at Center for Pharmaceutical Integration LLC, which provides consultation service to the industry in the area of CMC support &Technology Integration and Transfers (mergers & acquisitions). He retired as Sr. Director and Head of CMC Therapeutic Area Management function at Pfizer/ Wyeth Inc. NY. He had responsibility… Continue reading Mukund Mike Yelvigi

Nicholas Bohensky

Nicholas Bohensky is currently the Manager-Process at Wood for their Foster Wheeler Fired Heaters product line, with the primary responsibility of thermal and hydraulic design of fired process heaters and ancillary equipment. He has over 25 years of experience in this topic, as well as in proposal development, applications engineering, staff management and training, and… Continue reading Nicholas Bohensky

Paolo Giacomoni, Ph.D.

Dr. Paolo Giacomoni is an independent consultant to the Skin Care Industry. He is a quality-focused leader with over 25 years experience in Product Research and Development for cosmetic product providers. He was Chief Scientific Officer of Elan Rose International. He served as VP of Skin Care Worldwide R&D with Herbalife. He was Executive Director… Continue reading Paolo Giacomoni, Ph.D.

Peter Smallwood Ph.D.

Dr. Peter Smallwood is a surface/colloid chemist with practical experience of the development and manufacture of polymers, coatings, cleaning products and disinfectants. He has developed antibacterial and cleaning formulations and developed a process for manufacturing antiseptic nitrile examination gloves. Dr. Peter Smallwood is the Director of Chemical Associates, a UK based independent technical and training… Continue reading Peter Smallwood Ph.D.

Philip E. Sax

Phil Sax is an early thought leader for CSV. A Founder and President of Weinberg Spelton and Sax, a Computer System Validation Consultancy, he has been involved in hundreds of successful validation projects. He has trained more than 1000 professionals, including FDA staff, and has served as Vice President and Chief Regulatory and Quality Officer… Continue reading Philip E. Sax

Rachel Monsef

Rachel Monsef is a consultant to the biopharmaceutical and pharmaceutical industry for analytical and quality control. She has 19 years experience working with many types of assays for all stages of drug development. Ms. Monsef has been responsible for method development, method qualification, method validation, assay transfers, characterization work and stability studies. She has been… Continue reading Rachel Monsef

Ranjit Barshikar

Ranjit Barshikarhas 51 years of Pharmaceutical / Biotechnology Industry Experience in Quality, R&D, Mfg., and Regulatory. He is experienced in Quality Systems, Manufacturing Excellence, and the US and Foreign GMP Compliance. He being a QbD expert, has trained more than 1500 Scientists from Global Multinational & Generic Cos., on QbD implementation & ANDA filings for… Continue reading Ranjit Barshikar

Renée B. Galkin

Renée B. Galkin is a quality management consultant with over 30 years experience in the pharmaceutical and device industries. Prior to starting her consulting business, Ms. Galkin was part of two major companies: Science Management Corporation – a multinational consulting firm and then Wyeth/Pfizer where she gained her pharmaceutical experience during her 20 year association.… Continue reading Renée B. Galkin

Ricardo Diez, Ph.D

Ricardo Diez, Ph.D, is currently an Adjunct Professor at Rutgers University where he teaches two courses on cosmetic science in the Master of Business and Science. He has more than four decades of experience in Research and Development and Product Development in the industry in both consumer product companies while employed with Procter & Gamble,… Continue reading Ricardo Diez, Ph.D

Sam Morell

Sam Morell is a Chemical Engineering graduate of New York University and founder of S.P. Morell and Company. With over 40 years in the Chemicals industry, his experience includes both technical and marketing positions at Rohm and Haas, BASF, and Air Products and Chemicals. Mr. Morell has authored numerous technical articles on additives, pigments, and… Continue reading Sam Morell

Samiul Amin

Samiul Amin is currently Associate Professor of Chemical Engineering at Manhattan College. He also holds an Adjunct Associate Professorship at Long Island University, School of Pharmacy. Prior to joining academia in March 2018, Prof. Amin has worked in industry for the past 20 years working across Engineering, R&D and Innovation Management in global multinationals such… Continue reading Samiul Amin

Shrinivas (Cheenu) Murti, Ph.D.

Shrinivas (Cheenu) Murti is Executive Director, Global Regulatory Affairs – CMC at Merck & Co., Kenilworth, NJ. He has a B.Pharm. from the University of Bombay, India, a Ph.D. in Pharmaceutical Sciences from the University of Missouri and an MBA in General Management from Rutgers University. Prior to Merck, Cheenu worked at Organon and Schering-Plough,… Continue reading Shrinivas (Cheenu) Murti, Ph.D.

Stephen R. Schwartz

Stephen R. Schwartz, is a consultant on claims support for Stephen Schwartz and Associates as well as the founder and former President and CEO of IRSI with over 50 years of experience in conducting claim support clinical trials. Mr. Schwartz has worked on some of the industry’s largest and most influential cosmetic launches over the… Continue reading Stephen R. Schwartz

Steve Herman

Steve Herman is President of Diffusion LLC, a consulting firm specializing in regulatory issues, intellectual property, and technology development. He has been an Adjunct Professor in the FDU Cosmetic Science Program since 1993, teaching the Cosmetic Formulation Lab and Perfumery. Steve was a columnist for GCI Magazine for 17 years and has written a book,… Continue reading Steve Herman

Stuart Lee Friedel

Stuart Lee Friedel is a partner in the Advertising, Marketing & Promotions; Intellectual Property and Digital Media, Technology & Privacy Practice Groups of Davis & Gilbert LLP. He represents numerous multinational, national and local advertising agencies, advertisers, direct marketers, telemarketers and infomercial producers in connection with all aspects of advertising, promotions, marketing, direct marketing and… Continue reading Stuart Lee Friedel

Zeinab Schwen

Zeinab Schwen is an experienced technical expert, writer, lecturer, and entrepreneur with over 39 years in the pharmaceutical and medical device industries. While working for major pharmaceutical companies, Ms. Schwen gained hands-on experience in drug metabolism, drug development, and clinical trial management. She monitored large multicenter trials and participated in writing and preparing large drug… Continue reading Zeinab Schwen