Dwain L Sparks Email and Phone Number

My area of expertise, interest, and passion is centered on USP standards for solid oral and liquid oral packaging. Specifically, I focus my attention on WVTR (MVTR) testing of blisters and bottles as described in General Chapter USP <671>, one critical to the industry. I also am current with the testing requirements in USP <661>. I partner with a leading test lab in the USA and can provide a smooth transition for your testing program and help develop a testing strategy.

Sparks Consulting Services LLC offers 39 years of experience in the pharmaceutical business to its clients. Dwain L Sparks, owner, supported post approval drug substance (API) and drug product registrations for over 10 years. He has deep expertise in pharmaceutical packaging standards (guidance and regulations), globally, and is an Expert with YourEncore.As a past member of the USP Packaging and Storage Expert Committee (2008-2010), he offers a rich portfolio of knowledge-based… Show more Sparks Consulting Services LLC offers 39 years of experience in the pharmaceutical business to its clients. Dwain L Sparks, owner, supported post approval drug substance (API) and drug product registrations for over 10 years. He has deep expertise in pharmaceutical packaging standards (guidance and regulations), globally, and is an Expert with YourEncore.As a past member of the USP Packaging and Storage Expert Committee (2008-2010), he offers a rich portfolio of knowledge-based applications of the USP Standards for pharmaceutical packaging. He was instrumental in establishing the frame-work for recent revisions of USP General Chapter <671> Containers-Performance Testing, and his more recent research led to improved testing methods for the determination of water vapor transmission rates of plastic container closure systems, e.g., bottles and blisters, using water in place of desiccant as the substrate in the WVTR test method. Staying current with packaging standards, globally, is essential for the pharmaceutical business. Sparks can provide summaries of these standards and assist in implementation in your business.Sparks Consulting offers a range of document preparation for pharmaceutical applications (NDA, Dossier or Common Technical Documents). He has experience writing Type III Drug Master Files (DMFs for packaging materials and components), which are used broadly in the packaging industry and can provide a seamless reference for FDA reviews of product registrations.Sparks has published a number of articles about packaging standards and presented this information at conferences and workshops, globally. Following his retirement from Eli Lilly and Company (after 39 years) he is in a great position to partner with you or your firm to continue advancing the communication pathways among industry, government agencies (FDA, others), and standards bodies (USP, EMA, ASTM, others). Show less

Regulatory Expertise in pharmaceutical CMC (Chemistry, Manufacturing, and Controls) for new product development and post approval changes:- Solid oral dosage forms (SODF)- Liquid oral dosage forms (LODF)- Injection product- CTD Content for S.6, P.2.4 and P.7- Type III Drug Master Files (DMF)- Post approval Project Management (Annual Reports, Supplements (CBE, PA), Amendments)- Packaging (container closure system) development, testing, specifications, and test method… Show more Regulatory Expertise in pharmaceutical CMC (Chemistry, Manufacturing, and Controls) for new product development and post approval changes:- Solid oral dosage forms (SODF)- Liquid oral dosage forms (LODF)- Injection product- CTD Content for S.6, P.2.4 and P.7- Type III Drug Master Files (DMF)- Post approval Project Management (Annual Reports, Supplements (CBE, PA), Amendments)- Packaging (container closure system) development, testing, specifications, and test method development- Regulations, standards, guidance surveillance and watchdog- FDA relations and influence- USP relations and influence- ASTM relations and influence- ISO Standards content expertise and influence- Pharmapendium research- Contract (CMO) testing liaison- Project management for collecting, assembling, and finalizing comments for draft standards, regulations, and guidance (FDA - CDER, CBER, CVM; USP, PhEu, China)Primary packaging testing- Compendia Standards (USP, PhEur, JP)- Incoming specifications- WVTR (MVTR) according to USP <671> and alternate testing using water-filled samples in place of desiccant Show less

Sparks worked with Daphne Allen, UBM Canon, to find speakers and panelists for 2 sessions of this conference. One session focused on the mandatory conversion of Drug Master Files (DMFs) into electronic format following CTD guidelines for content (eDMFs). The second session (Keynote Speaker, Desmond Hunt, PhD, USP Senior Scientific Liaison) focused on updates to USP chapters about packaging chapters. The highlight of his presentation and the following panel discussion, facilitated by Sparks… Show more Sparks worked with Daphne Allen, UBM Canon, to find speakers and panelists for 2 sessions of this conference. One session focused on the mandatory conversion of Drug Master Files (DMFs) into electronic format following CTD guidelines for content (eDMFs). The second session (Keynote Speaker, Desmond Hunt, PhD, USP Senior Scientific Liaison) focused on updates to USP chapters about packaging chapters. The highlight of his presentation and the following panel discussion, facilitated by Sparks, was about the newly revised chapter, USP <661> Plastic Packaging Systems and Their Materials of Construction. This article (Author: Daphne Allen, Editor PMPNews, provides a great summary of the session: http://www.packagingdigest.com/standards/pmp-its-your-product-and-you-know-the-risk-you-determine-the-testing-160707 Show less

Sparks provided an update to changes in the USP Packaging Chapters and facilitate additional speakers and an expert panel discussion on the impact of the changes on the industry. Please visit this website (http://pharmapackna.pmpnews.com/conferencesseminars) for more information about this Conference on June 9-10, 2015

After leaving Regulatory Affairs for Marketed Drug Products at Lilly in 2003, I joined this Packaging Development Group as a result of my expertise in Drug Product and API container closure system (packaging) standards, regulations, and guidance. During this past 11 years, I have developed deeper expertise in global packaging standards, including influencing new and changing standards (USP, PhEur, JP, ISO, ICH, ASTM). In addition, I have worked closely with FDA scientists in the field of… Show more After leaving Regulatory Affairs for Marketed Drug Products at Lilly in 2003, I joined this Packaging Development Group as a result of my expertise in Drug Product and API container closure system (packaging) standards, regulations, and guidance. During this past 11 years, I have developed deeper expertise in global packaging standards, including influencing new and changing standards (USP, PhEur, JP, ISO, ICH, ASTM). In addition, I have worked closely with FDA scientists in the field of packaging guidance documents. Most recently, my work with revisions to the 1999 Container Closure System (Packaging) Guidance has been most important.I have partnered with packaging engineers and scientists and developed testing methods for packaging components and systems. Most notably has been my development of an alternate testing method for permeation of solid oral drug product container closure systems using water in place of desiccant. A Stimuli Article will appear in the Nov/Dec PF (40.6), 2014 at www.usp.org. This work has been announced publicly and this upcoming article in the USP Pharm Forum will detail this work.Being a scientist, I have taken a scientific approach to problem solving and development projects. This position will complete my career of over 39 years at Eli Lilly and Company. Show less

Member of the USP Packaging and Storage Expert Committee. Chair of the Advisory Panel to initiate important revisions to USP <671> Containers-Performance Testing.

From 1992 to 1997, I supported Pharmaceutical Drug Substance and Final Veterinary Drug Product Registrations while at Lilly's facility in Lafayette, IN (aka Tippecanoe Labs or Tippe Labs). I served as a project leader for gathering information for process, analytical method, raw material, intermediate changes which were submitted to FDA (CDER and CVM) via supplements and annual reports. During this assignment, I reviewed all changes and deviations with potential regulatory impact.