Cosmetics and personal care industry quality professionals, don’t miss the exciting opportunity to engage firsthand with FDA regulators and industry quality leaders at PCPC’s GMP Workshop, “Partners in Quality Excellence.” The workshop will feature one general session followed by four concurrent breakout sessions and a closing panel discussion. Participants will attend each breakout and rotate through all four sessions: Inspections, Data Integrity, Validation and Method Verification/Validation.
Registration is limited to 100 to guarantee interaction between attendees, the FDA and industry leaders. Agenda to be posted very soon!
About the Speaker
Jeffrey D. Meng
FDA Program Division Director/District Director, ORA, Division of Pharmaceutical Quality Operations III
Jeffrey Meng is an engineer officer in the U.S. Public Health Service and currently serves as the program division director for the Division of Pharmaceutical Quality Operations III within the ORA Office of Pharmaceutical Quality Operations. Meng leads over 70 FDA pharmaceutical investigators, compliance officers, management, and support staff responsible for facility inspections, investigations, and compliance throughout the Midwest and internationally in support of FDA’s mission to provide safe and effective pharmaceuticals for consumers.
Meng began his FDA career in 2009 as an investigator, with advancing roles as a Drug Specialist, Supervisory Investigator, and Director of Investigations Branch prior to his current position as the Program Division Director. He leveraged broad experiences throughout his FDA career, including rotations to the FDA Office of International Programs (OIP) China Office in Shanghai, China and to the FDA Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS). Meng obtained his B.S.E. and M.S.E. in Biomedical Engineering from the University of Michigan and is an ASQ (American Society for Quality) CPGP (Certified Pharmaceutical GMP Professional).
About the Speakers
Senior GMP Consultant and GMP Business Development Leader, ESi
Steve Greer is a senior GMP consultant and GMP business development leader for ESi. He provides GMP and quality consulting to the drug and cosmetic industry. He is also an engaging and inspiring keynote speaker, and executive coach working with Fortune 50 to small businesses. Greer speaks on leading change, improving performance, and increasing employee engagement. His audiences include both international and domestic conferences in many sectors.
Greer recently “graduated” after 35 years from the Procter & Gamble Company where his last role was the External Engagement Leader in Corporate Quality Assurance. His career included leadership roles in manufacturing and quality spanning P&Gs pharmaceutical, health & beauty and home care businesses. In his last role, he was responsible for building collaborative relationships with the FDA and industry as well as strengthening internal capability. In 2017, he was awarded the James N. Gamble Award, the highest recognition to individuals in Quality Assurance who have made outstanding leadership contributions.
Greer has served on the core team of the ISPE Advancing Pharmaceutical Quality initiative and has been co-chair of the Quality Assurance Committee of the Personal Care Products Council for many years. He previously served as the chairman of the Pharmaceutical Industry Association of Puerto Rico’s QA committee. Greer has been an industry leader in working with FDA on Quality Metrics and most recently Quality Management Maturity.
Greer and his wife also lead Genesis Counseling Center with offices based in Virginia where they serve over 6,000 clients a month from multiple locations.
Drug National Expert, FDA
Sandra Boyd is a Drug National Expert for the Pharmaceutical Quality Program Branch of the USFDA. She began her FDA career in 2009 as an investigator performing complex drug inspections throughout the United States as well as internationally. She has spent four years with the Division of Foreign Pharmaceutical Quality (foreign cadre) as well as a detail in the China Office in Beijing. Sandra currently splits her time between performing inspections and training new investigators on sterile inspections as well as data integrity. Prior to coming to FDA, she worked 17 years in the pharmaceutical industry, with the last role being the Director of Quality and Regulatory for an API manufacturer.
Chief Compliance Officer, Amway
Kristina Parkanzky is currently the Chief Compliance Officer in Quality Assurance for Amway. She has been with Amway for 17 years and over this time has distinguished herself as a highly effective Lab Chemist, Quality Engineer, and Quality Assurance Leader. Parkanzky has led the QA team through many local & international regulatory and certification audits while supporting the Quality Assurance internal audit team. She is dedicated to ensuring Amway’s manufacturing processes & products meet or exceed customer expectations and all applicable regulatory requirements.
Method Verification, Validation, Transfer
About the Speakers
Director, Pharmaceutical and Personal Care Services Industry, Q Laboratories
Cathleen Owen is the director of Pharmaceutical and Personal Care Services for Q Laboratories located in Cincinnati, Ohio. Cathleen has extensive experience in the pharmaceutical, cosmetic and beauty care industries having spent time at Merck, Elizabeth Arden, Barr Laboratories and KDC (Tri Tech Labs, Inc.) where she served as Sr. director of Quality and Regulatory Affairs. In her current role at Q Laboratories, Owen works with cGMP focused clients providing technical support for areas including laboratory testing, validation studies, stability studies, water system qualifications and regulatory compliance. She holds a B.S. in Chemistry from North Carolina State University and is currently chair of the Quality Assurance Committee for the Personal Care Products Council (PCPC).
Compliance Officer, FDA
Russ Riley is a compliance officer with the Office of Pharmaceutical Quality of Operations, which is within FDA’s field organization, the Office of Regulatory Affairs. His primary responsibility is the review and pursuit of enforcement actions against firms involved in the production, testing, packaging, labeling, and distribution of drug products and active pharmaceutical ingredients (APIs) that are found to be in violation of the Food, Drug, and Cosmetic Act.
Prior to this position, Riley was an Investigator, conducting inspections and other field activities that gathered evidence for enforcement actions. His experience with the FDA includes covering a wide variety of types of drug products and APIs in both domestic and foreign facilities. His office is in the Chicago area. Prior to working for the FDA, Riley worked in analytical chemistry and regulatory affairs in the pharmaceutical and medical device industries. He has a BS in Biology from the University of Illinois at Urbana-Champaign.
Vice President, Global Quality Systems, The Estée Lauder Companies
Don Ye has worked the past 19 years for The Estée Lauder Companies Inc. (ELC). His tenure at Estee Lauder started in Canada leading the Quality organization supporting the manufacturing, distribution, and R&D (Toronto/Markham, Canada). In 2014, Ye started to hold roles leading global Estee Lauder programs such as Validation and Data Integrity. For the past 3 years, he has been leading the Global Corporate Quality team (and at times holding interim position as NA Quality lead and Supplier Quality lead).
Ye is an experienced Quality Assurance and R&D professional with a demonstrated history of working in the cosmetics industry. Strong professional skilled in Manufacturing, Management, Consumer Products, Government Relations, and Continuous Improvement. He hails from the wonderful country to the north, Canada where he attended the University of Toronto where he earned degrees in Bachelor and Master in Science. Prior to working for ELC, Ye’s career path has led him through both Food and Cosmetic industries spending time with George Weston Group, Loblaw Corp, Unilever and privately owned cosmetic contract manufacturing.
About the Speakers
Partner, Covington & Burling, Los Angeles, Calif.
Wade Ackerman advises companies and trade associations on complex and novel FDA regulatory issues that require coordinated legal, regulatory, and public policy strategies.
Through more than 16 years of experience in private practice and positions within the FDA and on Capitol Hill, Ackerman has acquired unique insights into the evolving legal and regulatory landscape facing companies marketing FDA-regulated products. He co-leads Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable global resources to advise life sciences and technology clients harnessing the power of information technology and data to create new and cutting-edge innovations to improve health and achieve better outcomes for patients.
Partner, Covington & Burling, Los Angeles, Calif.
Drawing from more than a decade of experience both working at FDA and in private practice, Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress.
She assists clients in complying with U.S. regulatory requirements for foods, dietary supplements, cosmetics, OTC drugs, and animal products, and has specific expertise advising on FDA’s import and export requirements across all product categories. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention. Chambers USA reports that O’Connell “is enthusiastic, exceptionally smart and a talented lawyer who brings tremendous insight from being a regulator” and that she “knows how best to interact with the FDA in a productive and efficient way.”
Data Governance: Integrity and Management
About the Speakers
Senior Manager, Corporate Quality, Mary Kay
Tim Parrent is the senior manager of Corporate Quality at Mary Kay responsible for global governance and compliance, supplier quality management, and external engagement.
Parrent serves as the vice chair of Personal Care Products Council Quality Assurance Committee. He also represents industry as a subject matter expert serving on the NSF Joint Committee on GMP for OTCs responsible for NSF/ANSI 455-4-2021 Good Manufacturing Practices for OTCs and on the NSF Joint Committee on GMP for Cosmetics responsible for NSF/ANSI 455-3-2021 Good Manufacturing Practices for Cosmetics, as well as the ISO 22716 Cosmetics – Good Manufacturing Practices Technical Advisory Group.
Parrent has held numerous positions with the America Society for Quality (ASQ) Food, Drug, & Cosmetic Division, served on ASQ’s Technical Community Council and its Technical Community Council Advisory Board. He is an ASQ Certified Manager of Quality/Organizational Excellence. Parrent is also an active member of Gartner’s Quality Leadership Council.
Prior to joining Mary Kay, Parrent was a senior consultant for PriceWaterhouseCoopers’ Supply Chain Practice.
Drug Investigator, FDA
Justin Boyd is an FDA drug investigator with the Division of Foreign Pharmaceutical Inspections. Boyd has a Bachelor of Science degree in Microbiology from the University of Wisconsin. He began his FDA career in 2008 as an investigator performing drug and dietary supplements domestically and internationally. During his FDA career he has worked with the dedicated drug foreign cadre, served on details in the FDA China Office, conducted biological drug inspection for the Office of Biological Products, and spent three years as the FDA National Expert for Dietary Supplements. Boyd currently performs foreign drug inspections and is involved with FDA training of regulators and industry on data integrity, drug GMP, and dietary supplements.
Quality Assurance Manager, Procter & Gamble
Nelson Webb is P&G’s Data Integrity Leader as part of the Corporate Center QA team. He has over 30 years of experience in manufacturing and quality assurance for OTC drugs, cosmetics, and food products. Webb has worked extensively on start-up of new operations and strengthening of quality systems in the US and in Canada. Webb received a Bachelor of Science degree from the University of Tennessee with focus on management of production and supply chain operations.
About the Speakers
Corporate Quality Assurance Manager, Henkel
Tim King is Manager of Corporate Quality Assurance at Henkel has direct responsibility for Beauty Care manufacturing and supplier quality management. He leads many areas of GMP compliance responsibility within Research & Development and manufacturing operations in North America.
Tim holds a Bachelor of Science degree from the University of Waterloo, Waterloo, Ontario, Canada. Tim has worked in Quality Assurance/Quality Control for over 35 years in Canada and the US. He is a Certified Quality Engineer and has been a member of the American Society for Quality since 1990. Tim has been an active member of the Personal Care Products Council (PCPC), Quality Assurance Committee and Cosmetics Alliance of Canada (CCFTA) Quality Sub-Committee.
Associate Director, Global Quality, Colgate-Palmolive
Debi Chinsky is the associate director of Global Quality at Colgate-Palmolive. In this role, she provides strategic oversight on all Quality Systems, Certification and Compliance activities globally. She works actively with both R&D and Manufacturing teams to ensure they remain current and adherent to FDA regulations.
Debi has over 30 years’ experience working in both the Consumer Goods and Pharmaceutical industries. She holds a Bachelor of Science degree in Chemistry from Montclair University, Montclair, New Jersey. She is a Certified Quality Engineer and Senior member of the American Society for Quality.
Pre-approval Manager and Drug Specialist, Office of Pharmaceutical Quality Operations (OPQO) Division III, Office of Regulatory Affairs (ORA), FDA
Lauren Howard began her career with FDA in 2014 as a drug investigator conducting a wide-range of pharmaceutical inspections both domestically and internationally. In 2019, Howard became a Drug Specialist for the Agency. She has carried out over 250 complex domestic and international inspections resulting in warning letters, import alerts, recalls, regulatory meetings and injunction. In 2023, Howard transitioned to her new role as the Pre-approval Manager for OPQO Division III under FDA’s Office of Regulatory Affairs. In this role, she evaluates facilities listed in applications in partnership with FDA’s Center for Drug Evaluation and Research (CDER). She holds a Bachelor of Science degree in Neuroscience from the University of Cincinnati.
Experience Chicago from the heart of the city at the Loews Chicago Hotel. Loews Chicago Hotel is part of a highly visible 52-story tower located just one block north of the Chicago River and two blocks east of The Magnificent Mile — offering city skyline and lake views from the 400 guestrooms, including 25 luxury suites, and spectacular views from public space both indoors and out.
Group Rates Available: March 27-31, 2023
Guest Room Rates: Starting at $169 per night
Group Block Closes: Feb. 27, 2023
Group Details: Nightly Destination Fee is waived for registered group guests only.
Member Price: $695
Nonmember Price: $995