Welcome! Our goal is to provide you with industry updates on a routine basis. Each update of "In The Know" will bring you news of industry events, presentations, conferences, and educational information.

We hope you enjoy Lyophilization Technology's (LTI) "In The Know". Look for our next update of the latest news!
Announcements:
LTI Welcomes New Finance Manager, Kim A. Michele

Kim A Michele holds the position of Finance Manager at Lyophilization Technology, Inc. overseeing the Accounting and Finance Operations company as the company continues to grow and expand all areas of operation. She began working with LTI in 2018 as a consultant. Kim has over 30 plus years of experience in Accounting, Business Analytics, Cash Management, Human Resources and Compliance Management. The majority of Kim’s experience has been in the Retail Sector most recently for Sears Holdings Corporation located in Hoffman Estates, IL.

She has held many titles and lead Business Analytic teams at District, Regional and Corporate levels and has served as a Senior Analyst and Corporate Operational Compliance Manager.
Kim’s background also includes experience as a Controller in the Manufacturing Industry and a Consulting Engineering Firm in Western New York. Kim has attended Holy Family University and the University of Hawaii (Manoa) and holds a BS Degree in Business Administration. She continues her pursuit of Knowledge while presently attending classes at Princeton University. Kim has served on Community and Educational Boards in the Delaware Valley and has been actively involved with the March Of Dimes, Lupus Foundation and the Variety Club, both in Western New York and Philadelphia..
 
LTI Welcomes New Associate Director, Quality Assurance, Carolyn L. Hartman-Rakus

Carolyn Rakus, Associate Director of Quality Assurance, is responsible for providing guidance to the company in support of the preparation of toxicological and clinical studies materials for clients. This requires directing, working with, and providing instruction to QA staff and support to Project Directors. As the Associate Director of Quality Assurance, she is to assure effective execution of the necessary procedures in completing a project using her working knowledge of appropriate methods, techniques, and compliance to all associated regulatory requirements.

Carolyn holds a Bachelor of Science degree from Gwynedd-Mercy College in Business Administration and a Drug Development Certification from Temple University School of Pharmacy. She has over thirty years’ experience in the generic pharmaceutical, clinical and contract services industry performing diversified duties, as well as setting up Quality Departments and Systems. Carolyn has provided support as the compliance lead for a complete facility renovation project/expansion. She has helped implement systems to expand services and assist in global harmonization of systems, documentation, and procedures
Recent Industry Contributions:
"Identifying Target Product Profiles and Establishing Critical Quality Attributes to Support Lyophilized Product Specifications in Dual Chamber Pre-Filled Cartridge or Syringe"

Denise L. Miller and Edward H. Trappler
A Quality Target Product Profile (QTPP) and design input are a summary
of the desired finished drug product characteristics of a drug / device
combination product which should be established during early development.
Lyophilized parenteral drug products have unique QTPPs. When coupled with
a dual chamber device as the primary packaging and medical delivery system,
these QTPPs need to align with the device design inputs to ensure the final
product is suitable for its intended use. The data and information for both the
drug product and device must be thoroughly documented as part of a Design
History File.

"Lyophilizer Instrumentation Calibration: Principles & Practices"

Denise L. Miller, Quality Assurance Associate LTI
Edward H. Trappler, President LTI
Jason Zagorski, LTI

Historically, the pharmaceutical industry's focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. Recently, focused attention has been given to control and monitoring instrumentation for lyophilization.

This article was published in ISPE in the July/August 2020 issue. To review the full article, please click here
To Plan, Secure and Serve:

During this uncertain and unnerving time of living and working through the pandemic our best defense in battling COVID-19 is science, evidence, and reason. With a responsible attitude, plans and measures have been put in place to protect our most valuable asset and resource, the LTI staff. As responsible professionals, we have altered our work habits, all showing up for work, to be on site or working from home, sometimes working irregular schedules, sometimes long hours. We have arranged activities to allow us to continue supporting our client’s endeavors, keeping development projects on track and on time.

As we continue to live through this public health emergency and learn more about the epidemiology of SARS-CoV-2, we constantly adjust the plans and measures to deal with what has become our more common routine. We will continue to strive to protect ourselves and secure our ability to provide services to our clients. We recognize the part we play and our responsibilities in the development of new products for the benefit of patients in need. We realize bringing a new product to patients is a long-term endeavor. We are committed to assure our services and client support are not deterred by these hopefully short-lived conditions.

Edward H. Trappler
Industry Events: 

Due to Covid-19, all industry events have been canceled, postponed or will be held as a virtual event.
Please see details below for more information.


AAPS PharmSci 360 Virtual Meeting
October 26 - November 5, 2020
AAPS PharmSci 360 will now be a virtual event. For further information, please click here.


For more events, visit our website!