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Overcoming Analytical Testing Inconsistency from Global Perspective

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Pritesh Kumar
Managing Director at PhytoSciences Consulting LLC
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Concentration 2019
May 30, 2019, Pala, USA
Concentration 2019
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About speaker

Pritesh Kumar
Managing Director at PhytoSciences Consulting LLC

Dr. Pritesh Kumar earned his Ph.D. in Pharmacology and Toxicology, with a focus in cannabinoid (cannabis) pharmacology, from the University of Louisville, Kentucky USA. Previously, Dr. Kumar conducted pharmacological testing of FDA- approved drugs as potential ligands for the cannabinoid receptor 2 (CB2) and investigated the pharmacology of cannabinoids.Dr. Kumar is currently an Advisor to the WHO (World Health Organization) based in Geneva, Switzerland. In this role, Dr. Kumar provides consultation services to the 40th Meeting of the Expert Committee on Drug Dependence regarding Cannabis Toxicology.Dr. Kumar is the Senior Managing Director of PhytoSciences, an international organization comprised of 40+ scientists based in India, Canada, Africa, Latin America, and the USA. The company consults in the areas clinical trial solutions, novel drug delivery technologydevelopment, industrial scale manufacturing, analytical testing, and commercial bioprocessing.Dr. Kumar is currently the Scientific Advisor for Addis Ababa University, School of Pharmacy (SoP) in Ethiopia. In this role, Dr. Kumar facilitates advancements in graduate student education, promotes the interest of the SoP, and develops relationships between the SoP andthe private sector.In addition, Dr. Kumar previously served as Chief Scientific Officer for PharmaCielo Ltd., a Canadian company with operations in Colombia, South America.

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This presentation will begin with an overview of the lack of standardization in cannabis testing and will take the audience on a global journey to understand why there is inconsistency and what new and existing management can do to ensure the laboratory is positioned to adapt to regulations. This presentation shall provide an overview of the testing regulations from the perspective of the FDA (USA), INVIMA (LATAM), Health Canada (Canada), EU (European Union), and African countries with cannabis programmes. This presentation will discuss the proactive approach that is needed to ensure all elements of the laboratory system are complying from a pharmaceutical testing perspective with an application to cannabis testing. The integration of cGMP aspects during construction to be considered to ensure a controlled environment will be discussed in addition to the proper categorization of by cGMP status and by cGMP critical or noncritical use. Furthermore, the lecture will provide the management with an overview of User requirement specifications (URS) and function requirement specifications (FRS) which are defined for design qualification (DQ) or for subsequent validation testing which play a critical role in Qualification (IQ/OQ/PQ). The final points that will be covered from an FDA perspective will be the integration of Q6A and 21 CRF 211 in the validation phase of testing.

02:10 Disclaimer

03:27 Objectives I

06:57 Objectives II

08:45 Global Problem

10:40 Global legalization implications

14:50 Canada

16:37 The EU

21:56 Africa

23:55 21 CFR 211

26:22 ICHQ2: Analytical procedures cont.

28:00 Conclusion

31:00 Acknowledgments

32:41 Standardization

34:00 CGMP

36:47 State regulations

39:00 Cannabinoid standards

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