Name: 48th Annual International Good Manufacturing Practices Conference 2024
Start: 05/03/2024 01:30 PM +00:00
End: 07/03/2024 05:15 PM +00:00

My name is Jennifer Ahearn and I have spent my career helping companies navigate the evolving regulatory landscapes for products around the world regulated by the US Food and Drug Administration (FDA), European Union (EU), Health Canada, Therapeutics Goods Association (TGA), and other regulatory authorities. The team at GMPACT are cGMP experts and we have spent years working with a wide variety of clients from startups to billion-dollar worldwide companies. We specialize in products such as sterile and non-sterile drugs (including compounded drugs), medical devices, OTCs, homeopathics, dietary supplements and now consumer beauty products.&nbsp;
GMPACT&rsquo;s regulatory and compliance group includes experienced employees, both ex-FDA and ex-industry, who provide comprehensive assistance through the manufacturing timeline, from pre-submission of pharmaceutical NDA/ANDA and medical device 510(k), to Manufacturing, Packaging and Testing.
The GMPACT goal is to provide support for quality, manufacturing, and regulatory issues so that our clients can maintain good manufacturing practices (GMP) while gaining efficiency in manufacturing. GMPACT uses a multidisciplinary team of regulatory professionals and scientists to accomplish that goal; a team that can assist the quality unit while solving and answering technical problems in manufacturing, laboratory and packaging.&nbsp;
GMPACT offers assistance through FDA compliance audits or through larger scope FDA 483 remediation activities. The GMPACT team has assisted manufacturers through FDA responses by providing audits, data review, writing investigations, mentoring on investigations, performing root cause analysis, gap assessments of Standard Operation Procedures (SOP) and Standard Test Procedures (STP) and validation packages; and reviewing analytical laboratory, manufacturing, and microbiological quality control and quality assurance systems.
GMPACT&rsquo;s team has developed quality systems from the ground up, beginning in early phase clinical trials and managed those systems until full transition to site personnel has taken place.&nbsp;
I have served numerous roles within the FDA and our passion at GMPACT is to help industry exceed regulatory compliance requirements, while maintaining practical manufacturing. We are dedicated to our clients and believe that through diligent and efficient efforts, manufacturing sites will achieve compliance, increase profitability, and have a system in place to maintain those efforts.

GMPACT

ABOUT US MVA Scientific Consultants is a full-service microscopy laboratory offering customized analytical testing. Since our establishment in 1990, we have worked on a variety of materials and collected a vast amount of experience and knowledge. We proudly serve a broad range of industries worldwide and have helped professionals including quality managers, scientists, investigators, and engineers.
OUR ACCREDITATIONS To ensure that our services are of the highest quality and backed by reliable and reproducible data, we are ISO/IEC 17025 certified. Our FDA and DEA registrations ensure full compliance with testing regulated products.
CLIENT CONFIDENTIALITY MVA Scientific Consultants maintains a strict proprietary information policy. The results of client projects are not released to any third parties unless authorized by the submitter or requested by state or federal law.

MVA SCIENTIFIC CONSULTANTS

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence&trade; delivers powerful insights with speed and agility &mdash; enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.
 IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA&rsquo;s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.

IQVIA Technologies

Redica Systems is a data analytics platform helping life sciences companies improve their quality and stay on top of evolving regulations. Our proprietary processes transform one of the industry&rsquo;s most complete data sets, aggregated from hundreds of health agencies and Freedom of Information Act (FOIA) sourcing, into meaningful answers and insights that reduce regulatory and compliance risk.
Our customers use Redica Systems to more effectively and efficiently manage their inspection preparation, monitor their supplier quality, and perform regulatory surveillance.&nbsp;
With human expertise, machine learning, and automation, we assimilate, normalize, and organize large amounts of unstructured data to make sure all entities are represented and connected. The Redica ID provides a real-time view into evolving data by tracking inspections, enforcement actions, regulatory publications, and M&amp;A activity. In a complex landscape that&rsquo;s always in flux, the Redica ID is a reliable constant.
Founded in 2010, Redica Systems serves over 200 customers in the pharma, biopharma, medtech, medical device, and food and cosmetics industries, including 19 of the top 20 pharma companies and 9 of the 10 top medical devices companies. Redica Systems&rsquo; headquarters are in Pleasanton, CA. More information is available at www.redica.com.

Redica Systems

8:15 AM
Predicting GMP Quality Risks at Manufacturing Sites Update on CDER&rsquo;s Quality Management Maturity Program Q&amp;A Panel - Jerry Chapman and Jennifer Maguire 
10:30 AM
Health System Insights for Regulators on Pharmaceutical Quality
Legal Perspective &ndash; Artificial Intelligence in Regulatory Operations Q&amp;A Panel - Philip Almeter, Rob Lodder, and Alan Minsk

48th Annual International Good Manufacturing Practices Conference 2024

Agenda

Speakers24 Speakers

Jennifer Ahearn

Kelly Smith

Michael Bartlett

Alonza Cruse

Robert Studt

Thomas Friedli

Eric Jayjock

Huiping Tu

Leslie Furr

Benjamin Stevens

Thomas O'Conner

Simone Pitts

Teresa Forlini

Kir Henrici

Kurt In Albon

Ashley Boam

Ileana Barreto-Pettit

Christine Feaster

Jerry Chapman

Jennifer Maguire

Philip Almeter

Rob Lodder

Alan Minsk

Ian Jackson

Booth4 Booth

GMPACT

MVA SCIENTIFIC CONSULTANTS

IQVIA Technologies

Redica Systems

48th Annual International Good Manufacturing Practices Conference 2024

Agenda

Speakers.css-88lm8f{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#575757;font-family:'Poppins',sans-serif;margin-left:0.8rem;}24 Speakers

Jennifer Ahearn

Kelly Smith

Michael Bartlett

Alonza Cruse

Robert Studt

Thomas Friedli

Eric Jayjock

Huiping Tu

Leslie Furr

Benjamin Stevens

Thomas O'Conner

Simone Pitts

Teresa Forlini

Kir Henrici

Kurt In Albon

Ashley Boam

Ileana Barreto-Pettit

Christine Feaster

Jerry Chapman

Jennifer Maguire

Philip Almeter

Rob Lodder

Alan Minsk

Ian Jackson

Booth.css-m0dvwy{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#575757;font-family:'Poppins',sans-serif;color:#FFFFFF;margin-left:0.8rem;font-weight:400;}4 Booth

GMPACT

MVA SCIENTIFIC CONSULTANTS

IQVIA Technologies

Redica Systems

Speakers24 Speakers

Booth4 Booth