Jennifer Ahearn, Vice Chair of the PQRI Steering Committee invites you to register for the 4th FDA/PQRI Conference on Advancing Product Quality!

4th FDA/PQRI Conference on Advancing Product Quality:
Patient Centric Product Design, Drug Development, and Manufacturing
April 9 – 11, 2019
Rockville, MD
http://pqri.org/4th-fda-pqri-conference/

REGULATORS WILL BE THERE. WILL YOU?

New: Call for Poster Abstracts (see below for details)

Dear Colleagues:

On April 9-11, 2019, FDA and PQRI will host the 4th FDA/PQRI Conference on Advancing Product Quality: Patient Centric Product Design, Drug Development, and Manufacturing at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center in Rockville, MD USA.

On-line registration is open. Register before November 1st to receive the early bird rate (save $200). We expect a very good turnout for this Conference, so please register early to save your seat. For a copy of the current draft program and to register, please visit: http://www.signmeup.com/126943.

The 4th FDA/PQRI Quality Conference will bring together leaders from regulatory agencies, industry, and academia to discuss key, critical topics in drug product quality. Input from attendees will aid in future FDA guidance development.

Following morning plenary sessions on Day 1 and Day 2, attendees will breakout into three themed concurrent tracks:

Track #1: Novel Approaches to Improve Treatment Outcome and Patient Safety
Providing the intended therapeutic effect, in a safe manner, is the centerpiece of a quality drug product. The complexity of novel formulations and modalities increases the needs for robust characterization of such products and integration of knowledge/data to first understand and subsequently project their clinical behavior. Novel characterization methodologies and tools and modeling and simulation approaches will be discussed towards these goals.

Track #2: Emerging Technologies and Patient Centricity in Early Drug Development
Current and future thinking on the role of new/emerging technologies in driving contemporary early development across the broad small-to-large molecule spectrum. Advancing understanding, dialogue and awareness of opportunities to “design in” patient centricity as a core attribute and consideration in early drug development to enhance the overall patient experience.

Track #3: Novel Manufacturing Technologies and Challenges for the Production of Patient-Centric Drug Products
The rapidly evolving manufacturing methods for gene and cell based therapies and continuous processes require new approaches related to analytics, validation and registration. This Track will explore each of these areas and the evolving expectations.

Day 3 will include a Special Plenary Session with FDA and the introduction of a new FDA initiative (details to come).

POSTER SESSION

FDA/PQRI Conference Organizers are inviting abstract submissions for scientific posters. Individuals and groups interested in presenting posters should submit an informative abstract by November 16, 2018. See Poster Abstract Guidelines for more information.

The Scientific Poster Session will be continuously accessible during Day 1 and Day 2 of the Conference (April 9 and 10). Awards for first, second, and third prize for “best” poster will be awarded on Day 3 (April 11). Attendees at the Conference will vote for the poster awards.

HOTEL ROOMS

Don’t forget to reserve your room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center. The special Conference room rate will be available until March 19, 2019 or until the group block is sold-out, whichever comes first. To reserve your room on-line, click here: Hotel Reservation.

REGISTER NOW

Jennifer Ahearn & Daniel Spankie will be presenting at the CHPA cGMP Workshop on November 12-13, 2018!

Sr. Managing Consultant and Practice Group Director Jennifer Ahearn and Sr. Consultant Daniel Spankie will be presenting at a Consumer Healthcare Products Association (CHPA) cGMP workshop on Monday, November 12th from 10:00 a.m. – 5:00 p.m. and Tuesday, November 13th from 8:30 a.m. – 12:30 p.m. The workshop, titled “Good Manufacturing Practices & Recent Inspection Findings for Human OTC Products” is open to all CHPA members and has an action-packed agenda, so spots are likely to fill up fast!

Laws, Regulations, and Monographs
Holding and Distribution
Organization & Personnel/Q10
Returned & Salvaged Drug Products
Buildings & Facilities
Laboratory Controls
Equipment
Records & Report
Control of Components & Drug
FDA’s Risk Based Approach to cGMPs
Production & Process Controls
FDA Inspection Trends
Packaging and Labeling Control
Data Integrity

Current Good Manufacturing Practices (cGMP) are the FDA’s formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. Pharmaceutical and biotechnology companies must follow cGMPs to ensure their products are manufactured to specific requirements including identity, strength, quality, and purity.

The “c” in cGMP serves to remind companies that they must employ up-to-date technologies and systems in order to comply with these regulations. What better way to stay abreast of the latest trends and developments than this workshop? If you or someone you know might be interested, visit https://chpa.org/OTCAcademy/cGMP_OTCs_101.aspx.

Jennifer Ahearn has been elected to be the Vice-Chair of the Product Quality Research Institute Steering Committee!

The Product Quality Research Institute (PQRI) is a collaborative process involving FDA’s Center for Drug Evaluation and Research (CDER), Industry and Academia. The mission of PQRI is to conduct research to generate specific scientific information that should be submitted in a regulatory filing to CDER. PQRI member organizations, representing industry, academia, and government, cover a wide array of scientific issues related to pharmaceutical products. Through its working groups and technical committees, PQRI tackles projects to ensure the quality, safety and performance of drug products.

Jennifer Ahearn – Speaker at CHPA’s Regulatory, Scientific & Quality (RSQ) Conference in Washington, D.C.!

Jennifer Ahearn (Director of Regulatory & Compliance – Engineering Systems Inc.) was a speaker during Quality Session #3 – Data Integrity in the OTC World. She was part of a panel with Tom Himmelsbach (North America Regional Quality Director – Johnson & Johnson Consumer Inc.) and Carmela Rosa, Psy.D. (Director, Division of Drug Quality I – Center for Drug Evaluation and Research, U.S. Food & Drug Administration). The moderator was Catherine Vicente (Senior Scientist, Research & Development – Johnson & Johnson Consumer Inc.).

The session focused on recent inspection findings from firms regarding Data Integrity. Speakers discussed best practices on data integrity (GMP, lab practices, data collection, electronic signatures, etc.). Participants heard a discussion of inspection findings and the expectations and impact of the new data integrity guidance.

Jennifer Ahearn presents at the 2018 GMP Conference at UGA!

The Regulatory team attended the 42nd International Good Manufacturing Practices Conference held at the University of Georgia March 12-15, 2018. The conference is co-sponsored by the FDA and the UGA College of Pharmacy. Speakers include FDA officials, international regulatory agency officials and experts from industry, all speaking on current trends in the Pharmaceutical Industry. Jennifer Ahearn, Director of Regulatory and Compliance – Pharmaceutical and Medical Devices spoke at this year’s conference on Change Control and the Impact on Quality. Change control is an important aspect of a QMS system and Jennifer discussed the change control process and challenges the industry faces in implementing an effective program.

Jennifer Ahearn and Daniel Spankie lead Post Conference Tutorial on ‘Internal Data Auditing’ at 2018 GMP Conference at UGA!

The Regulatory team attended the 42nd International Good Manufacturing Practices Conference held at the University of Georgia March 12-15, 2018. The conference is co-sponsored by the FDA and the UGA College of Pharmacy. Speakers include FDA officials, international regulatory agency officials and experts from industry, all speaking on current trends in the Pharmaceutical Industry. Jennifer Ahearn and Dan Spankie hosted the post-conference tutorial on Internal Data Integrity Auditing where the following points were discussed:

– How the principles of ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) would apply to specific lab systems such as Chromatography Data Systems (CDS), Laboratory Information Management System LIMS, and stand-alone analytical systems. What types of flags to look for in your electronic systems.
– Considerations for data integrity auditing of paper based systems.
– SOP recommendations for routine data auditing based on the FDA’s Data Integrity and Compliance with CGMP Guidance for Industry April 2016 Draft Guidance.
– Company culture and its’ impact on data integrity with recommendations for data governance polices.
– Data Integrity considerations for manufacturing controls and automated systems.

Daniel Spankie joins IVT Network Data Integrity Working Group

Daniel Spankie was recently accepted as a founding member of the Institute of Validation Technology (IVT) Network Data Integrity Working Group. The goal of the working group is to develop a data integrity handbook by August 2018. The handbook will include information on how to implement data integrity programs, assessments, workflows and examples. The handbook will also include a compilation and analysis of current global guidances to serve as an industry best practice document.

 

ESi Welcomes David Beck

Please welcome David Beck to the ESi team. David joins us as a Senior Staff Consultant based in our D.C. office, where he brings more than 20 years of experience leading and managing transportation projects, including complex technical engagements for government agencies and manufacturers in the motor vehicle and aviation industry. David specializes in transportation engineering design, safety, and regulatory policy, and has broad experience in roles involving design analysis, project management, production engineering, testing, and safety implementation. Throughout his career, David has established a strong track record of driving cross-team collaboration and delivery – successfully synthesizing both the overarching business objectives and the technical aspects of a project to ensure clear expectations and successful execution.

Prior to joining ESI, David served in key roles with several government regulatory agencies, including the Federal Aviation Administration, the National Highway Traffic Safety Administration, and the Pipeline Hazardous Materials Safety Administration. He also has extensive hands-on experience managing large scale, complex technical projects for major transportation manufacturers, including Honeywell Turbo Technologies, Pratt& Whitney, and General Electric Aviation.

David is a veteran of the United States Marine Corps. and earned a B.S. in Industrial Engineering from the University of Southern Mississippi and an M.B.A. in Marketing from the University of Phoenix. He is currently working toward an M.S. degree in Space Studies and Aeronautical Science at American Public University. David credits his PMP (project management professional) training with the skills that have enabled him to successfully navigate a range of diverse work environments and forge strong relationships with key stakeholders.

ESi Welcomes Daniel Spankie

We are pleased to welcome Daniel Spankie to the ESi team as a Senior Consultant in our Pharmaceutical & Medical Device sub-practice. Daniel will be based in our North Carolina office, where he brings over 19 years of experience in pharmaceutical and medical device regulatory compliance, and a broad background in electronic records/systems auditing and data integrity for regulated environments. Daniel also has specific expertise in quality control, chemistry, and analytical method development.

Daniel joins us from Waters Corporation, where he worked as an Informatics Specialist and partnered with regional account managers and service organizations to design and implement network solutions for regulated lab environments. While there, Daniel successfully designed and managed multiple large scale technology implementations for both site based and global cGxP networks, and served as the subject matter expert for data integrity audits.

Prior to his work at Waters, Daniel worked as Section Manager in the Chemical Quality Laboratory Systems and Compliance division of Hospira, Inc. where he was responsible for managing multiple laboratory and technical departments, and performing compliance audits of global API manufacturers and contract lab facilities. Additionally, Daniel spearheaded efforts to maximize use of laboratory hardware and software systems, and implemented key programs to minimize instrumentation downtime and ensure regulatory compliance.