Agenda

Faculty

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• Brandy Koslop, Senior Regulatory Affairs Manager, Ecolab Life Sciences

  
  Brandy Koslop has over 15 years’ experience in regulatory affairs and quality within the pharmaceutical and antimicrobial chemical industries. She started her career in Microbiologist with Celltech Pharmaceuticals in environmental microbiology and validation. Brandy joined Ecolab in March 2005 in as a Quality Assurance Auditor, and has since held various positions such as Quality Assurance Manager, Lean Six Sigma Black Belt and Global Biocide Registration Manager. In her current role, Brandy works directly with government agencies on regulatory initiatives and provides regulatory and technical support to Ecolab customers, advising on cleaning and disinfection, and manages third party laboratories that perform disinfectant efficacy studies.

• Grant Lindh, Senior Chemist, Ecolab Life Sciences

  
  Grant is a Senior Chemist at Ecolab for Global Life Sciences RD&E, supporting new product development and product portfolio management for offerings that serve Pharmaceutical, API, Biotechnology and Personal Care customers. As a formulation chemist, he brings technical expertise in building detergents for multiple industries and soil types. He works closely with Ecolab’s analytical team to develop corresponding test methods for detergent residues and works with customers to implement them during cleaning validations. He also provides testing advice and direction for Ecolab’s adjoining technical service group, helping to create and develop cleaning recommendations. Grant has worked at Ecolab for seven years in various product development roles.

• Sunil Patel, Senior Global Technical Leader, Ecolab Life Sciences

  
  Sunil has over 13 years of experience working in the engineering and validation fields of cGMP/FDA/EU/ ISO regulated industry sectors. Sunil has a strong background in cleaning validation (CIP, COP, manual), process validation, process design, clean utilities (WFI, PW, clean steam, clean air, clean gases), HVAC, project management, sterilization and processing equipment validation. Further expertise includes process optimization/improvement, regulatory compliance and risk management methodologies for the pharmaceutical and biologics industry

• Fred Ohsiek, Senior Cleaning Validation Specialist and Cleaning Validation Work Package Owner, Novo Nordisk

  
  Fred Ohsiek is the Senior Cleaning Validation Specialist and Cleaning Validation Work Package Owner for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered the cleaning validation subject matter expert in most positions held. His expertise includes developing, validating, and monitoring cleaning processes for equipment used to manufacture small molecule, peptide hormone encased, and large molecule pharmaceutical, OTC, and nutritional products. He has authored analytical and recovery methods to cleaning validation documents and has successfully defended legacy cleaning validation documents (i.e., created and legacy).

Sponsors

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  Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier – protecting people and vital resources.
  Website: https://www.ecolab.com/

Partners

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  American Pharmaceutical Review is the leading review of business and technology for the pharmaceutical industry throughout North America.
  Website: https://www.americanpharmaceuticalreview.com/

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  Keen insights into the major manufacturing issues facing the industry today.
  Website: http://www.pharmamanufacturing.com

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  Pharmaceutical Outsourcing is the leading review of business and technology for the pharmaceutical industry throughout North America.
  Website: https://www.pharmoutsourcing.com/

Venue

Pricing & Registration