ISPE-CaSA 2020 Women in Pharma Webinar: Transform and Empower Yourself, June 10,2020

Event Date
Add to Calendar ISPE-CaSA 2020 Women in Pharma Webinar: Transform and Empower Yourself, June 10,2020     Sponsored by ISPE CaSA Women in Pharma invites you to join us for an interactive webinar focused on diversity, inclusive behaviors, and mentoring on June 10 from 10 a.m. until 1 p.m. (Eastern).   During this webinar you will: Better understand how to create an environment that is conducive to inclusive behaviors. Understand why diversity is a powerful force for improving decision making. Leave with more insight into how their own brains work thus improving your self-awareness and effectiveness. Learn about how to engage in local ISPE mentor circles   All industry professionals are welcome to attend: Anyone (female or male) interested in learning more about behaviors behind diversity and inclusion Anyone (female or male) interested in learning how to transform and empower yourself in your career Students and Young Professionals welcome Coaches ISPE Members ISPE Non-Members   Keynotes: “Are We Naturally Inclusive?" - John Daniel, Chief Human Resources Officer, First Horizon Financial Corporation "Transform and Empower Yourself" - Rebecca Holland New, Managing Partner, RSR Partner Solutions   Visit our registration site for more information and to register.           Webinar . ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

 

WIP 6.10.2020 Image

 

Sponsored by

Avexis Logo

ISPE CaSA Women in Pharma invites you to join us for an interactive webinar

focused on diversity, inclusive behaviors, and mentoring on June 10 from 10 a.m. until 1 p.m. (Eastern).

 

During this webinar you will:

  • Better understand how to create an environment that is conducive to inclusive behaviors.
  • Understand why diversity is a powerful force for improving decision making.
  • Leave with more insight into how their own brains work thus improving your self-awareness and effectiveness.
  • Learn about how to engage in local ISPE mentor circles

 

All industry professionals are welcome to attend:

  • Anyone (female or male) interested in learning more about behaviors behind diversity and inclusion
  • Anyone (female or male) interested in learning how to transform and empower yourself in your career
  • Students and Young Professionals welcome
  • Coaches
  • ISPE Members
  • ISPE Non-Members

 

Keynotes:

  • “Are We Naturally Inclusive?" - John Daniel, Chief Human Resources Officer, First Horizon Financial Corporation
  • "Transform and Empower Yourself" - Rebecca Holland New, Managing Partner, RSR Partner Solutions

 

Visit our registration site for more information and to register.

 

 

 

 

 

ISPE-CaSA Student Chapter Virtual Resume Review - 5/25/20-5/29/20

Event Date
Add to Calendar ISPE-CaSA Student Chapter Virtual Resume Review - 5/25/20-5/29/20 Mock Interview/Resume Review Sessions   Sign up to attend as the ISPE CaSA Young Professionals host a Virtual Mock Interview/Resume Review the week of May 25th-29th! Polish your interviewing skills and gain insight on tips/tricks to gain traction on your resume views! Location: Virtual (accepting multiple platforms) Date: May 25th-29th Time: To Be Determined Between You and Your YP Volunteer Sponsored By: ISPE CaSA Young Professionals The purpose of this event is to support the 2020 recent graduating class as they enter the workforce during these trying times. Our YP volunteers will conduct 15-30 minute mock interviews and assist in reviewing resumes in addition to offering insight on proper networking etiquette. Click here to registration through Google Form     ISPE-CaSA Virtual Sessions . ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

ISPE Student Chapter logo

Mock Interview/Resume

Review Sessions

YP Interview image

 

Sign up to attend as the ISPE CaSA Young Professionals host a Virtual Mock Interview/Resume Review the week of May 25th-29th! Polish your interviewing skills and gain insight on tips/tricks to gain traction on your resume views!

Location: Virtual (accepting multiple platforms)

Date: May 25th-29th

Time: To Be Determined Between You and Your YP Volunteer

Sponsored By: ISPE CaSA Young Professionals

The purpose of this event is to support the 2020 recent graduating class as they enter the workforce during these trying times. Our YP volunteers will conduct 15-30 minute mock interviews and assist in reviewing resumes in addition to offering insight on proper networking etiquette.

Click here to registration through Google Form

 

 

ISPE-CaSA 2020 Annual Planning Session - September 17, 2020

Event Date
Add to Calendar ISPE-CaSA 2020 Annual Planning Session - September 17, 2020 REGISTER HERE     The ISPE-CaSA Board of Directors would like to invite you to the Annual Planning Session You will hear from each of our volunteer Board Members, discussing how we are adapting to the current times to service you, our membership. There will be opportunity to ask questions of the board, to tell us what YOU want from the Chapter, and to volunteer to serve in the Chapter. This is a COMPLIMENTARY VIRTUAL event, and registration is required to access the Session.       WE LOOK FORWARD TO SEEING YOU! REGISTER HERE Virtual ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

REGISTER HERE

 

 

The ISPE-CaSA Board of Directors would like to invite you to the Annual Planning Session

You will hear from each of our volunteer Board Members, discussing how we are adapting to the current times to service you, our membership. There will be opportunity to ask questions of the board, to tell us what YOU want from the Chapter, and to volunteer to serve in the Chapter.

This is a COMPLIMENTARY VIRTUAL event, and registration is required to access the Session.

 

 

2020-21 BOD

 

WE LOOK FORWARD TO SEEING YOU!

REGISTER HERE

ISPE-CaSA 2020 Education Webinar, December 8 - December 8, 2020

Event Date
Add to Calendar ISPE-CaSA 2020 Education Webinar, December 8 - December 8, 2020 REGISTRATION COMING SOON     REGISTRATION COMING SOON Virtual ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

REGISTRATION COMING SOON

 

EE Save the Date 10/7 and 12/8

 

REGISTRATION COMING SOON

ISPE-CaSA 2020 Education Webinar, Regulatory & Compliance - October 7, 2020

Event Date
Add to Calendar ISPE-CaSA 2020 Education Webinar, Regulatory & Compliance - October 7, 2020 REGISTRATION COMING SOON     REGISTRATION COMING SOON Virtual ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

REGISTRATION COMING SOON

 

EE Save the Date 10/7 and 12/8

 

REGISTRATION COMING SOON

ISPE-CaSA 2020 Education Webinar, Facilities Management - August 19, 2020

Event Date
Add to Calendar ISPE-CaSA 2020 Education Webinar, Facilities Management - August 19, 2020 REGISTER HERE     REGISTER HERE Virtual ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

ISPE-CaSA 2020 Education Webinar, Cell & Gene Therapy - June 3, 2020

Event Date
Add to Calendar ISPE-CaSA 2020 Education Webinar, Cell & Gene Therapy - June 3, 2020 ISPE-CaSA 2020 Webinar Series - Innovative Approaches Needed in Cell & Gene Therapy Production June 3, 2020 1:00 - 2:30 p.m. REGISTER HERE Applying Innovative PM Principles in Accelerating Cell and Gene Therapy Programs By Michael Gorman, PMP, LSSBB, Principal Consultant, DPS Group Uncertainty and complexity present innovators with countless challenges in developing early-stage cell and gene therapy programs. With a “patient, product, process” mindset, companies must navigate countless trade-offs to deliver safe and efficacious therapies appropriate for the product lifecycle stage. This presentation will discuss program management approaches seeking to find effective, harmonious solutions utilizing both traditional “left to right” milestone-based planning & controls with flexible, agile principles which foster innovation and enable flourishing through the expected unexpected.   Michael Gorman has over 20 years’ experience in guiding life science companies in navigating a risk-managed, best-value path from pre-IND to commercialization. With balanced experience as both manufacturer and service-provider, Mike has directed multiple, diverse cross-functional teams through the technology transfer process.   At DPS, Mike helps clients develop strategy and systems for their technology transfer, CMC, manufacturing supply chain, and alliance management programs, so they can quickly and effectively deliver quality therapeutic products.  He works with DPS clients across a spectrum of technologies and modalities, with a focus in biologics – including both traditional and advanced therapeutic cell and gene therapies.   Application of the FDA Guidance to Process Validation By Ramesh Maragh, Lead Technical Consultant, DPS Group This presentation will focus on application of the 2011 Process Validation Guidance and its importance to manufacturing robus and compliant products. It will draw in a case study on its relevance to the Life Science industry and show the interdependencies of the complex regulatory compliance, process develop and life-cycle management relationships.    Ramesh Maragh is a passionate and dedicated engineer, scientist, and leader that models the way to define the current manner that highly scientific, technical, and regulated drug products are formulated, scaled, and optimized for routine commercial manufacturing including technology transfers. With over 20 years of industry experience Ramesh has worked within Analytical Research and Development, Manufacturing Science and Technology, Quality Assurance, and Operations with expertise in process development, optimization, validation (PPQ), and commercial product support (Deviation/CAPA management). Ramesh enjoys mentoring teams on application of compliance and science to produce the best medicines for the betterment of mankind. REGISTER HERE   Thank you to our sponsors!   . ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

ISPE-CaSA 2020 Webinar Series - Innovative Approaches Needed in Cell & Gene Therapy Production

June 3, 2020 1:00 - 2:30 p.m.

REGISTER HERE

Applying Innovative PM Principles in Accelerating Cell and Gene Therapy Programs

By Michael Gorman, PMP, LSSBB, Principal Consultant, DPS Group

Uncertainty and complexity present innovators with countless challenges in developing early-stage cell and gene therapy programs. With a “patient, product, process” mindset, companies must navigate countless trade-offs to deliver safe and efficacious therapies appropriate for the product lifecycle stage. This presentation will discuss program management approaches seeking to find effective, harmonious solutions utilizing both traditional “left to right” milestone-based planning & controls with flexible, agile principles which foster innovation and enable flourishing through the expected unexpected.

Michael Gorman 

Michael Gorman has over 20 years’ experience in guiding life science companies in navigating a risk-managed, best-value path from pre-IND to commercialization. With balanced experience as both manufacturer and service-provider, Mike has directed multiple, diverse cross-functional teams through the technology transfer process.   At DPS, Mike helps clients develop strategy and systems for their technology transfer, CMC, manufacturing supply chain, and alliance management programs, so they can quickly and effectively deliver quality therapeutic products.  He works with DPS clients across a spectrum of technologies and modalities, with a focus in biologics – including both traditional and advanced therapeutic cell and gene therapies.

 

Application of the FDA Guidance to Process Validation

By Ramesh Maragh, Lead Technical Consultant, DPS Group

This presentation will focus on application of the 2011 Process Validation Guidance and its importance to manufacturing robus and compliant products. It will draw in a case study on its relevance to the Life Science industry and show the interdependencies of the complex regulatory compliance, process develop and life-cycle management relationships. 

Ramesh Maragh 

Ramesh Maragh is a passionate and dedicated engineer, scientist, and leader that models the way to define the current manner that highly scientific, technical, and regulated drug products are formulated, scaled, and optimized for routine commercial manufacturing including technology transfers. With over 20 years of industry experience Ramesh has worked within Analytical Research and Development, Manufacturing Science and Technology, Quality Assurance, and Operations with expertise in process development, optimization, validation (PPQ), and commercial product support (Deviation/CAPA management). Ramesh enjoys mentoring teams on application of compliance and science to produce the best medicines for the betterment of mankind.

REGISTER HERE

 

Thank you to our sponsors!

Jacobs logo

 

DPS Tagline

2020 ISPE Virtual Biopharmeceutical Manufacturing Conference & Workshop - June 1-4, 2020

Event Date
Add to Calendar 2020 ISPE Virtual Biopharmeceutical Manufacturing Conference & Workshop - June 1-4, 2020     ISPE-CaSA Members use promo code SAVE15% when registering by 18 May to save 15% on the combined conference and workshop registration.   2020 ISPE Biopharmaceutical Manufacturing Virtual Conference [ispe.org], taking place 1–2 June 2020 2020 ISPE Continuous Manufacturing Virtual Workshop [ispe.org], taking place 3–4 June 2020. What Can You Expect? Fully Loaded Agendas: Between the two events, you'll benefit from topic-focused presentations and panel discussions from 80+ global experts representing FDA, GSK, Kite Pharma, Merck, NIIMBL, Novartis, Roche, Sanofi, and more. Ease of Experience: The event portal is easy to navigate and will allow you to view presentations, participate in Q&A sessions with speakers, plus network and knowledge share with your fellow attendees. The 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference will also feature a virtual exhibitor experience. BONUS: You will receive access to the recording of all conference and workshop sessions for one year. Actionable Insights: Hear from global experts as they share their knowledge and lessons learned on advanced therapeutic medicinal products (ATMPs) such as cell and gene therapies, digitalization, single-use technology, implications of ICH Q12 for biopharma, and much more. Conference Featured Speakers: Wilson Bryan, MD Director, Office of Tissues and Advanced Therapies, FDA/CBER Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, FDA/CDER Lawrence Hill, PharmD, MBA, CEO, Gan & Lee Pharmaceuticals USA Corp. Carol Lynch, President, US and Head North America, Sandoz US Inc. Maria Hoffman, Executive Director, Engineering, Merck & Co Inc. Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB And More Workshop Featured Speakers: Rapti Madurawe, PhD, Director, Division of Process Assessment I, FDA/CDER/OPQ Stelios Tsinontides, Director, Office of Pharmaceutical Assessment, FDA Moiz Diwan, PhD, Director, Pharmaceutical Development Research & Development, AbbVie John Erickson, PhD, Senior Fellow, NIIMBL And More We genuinely believe you will find the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference [ispe.org] and the 2020 ISPE Continuous Manufacturing Virtual Workshop [ispe.org] to be more beneficial now than ever before and will provide you with solutions to critical challenges and information on possible changing of industry norms.  To explore the complete education agendas and to register, please visit ISPE.org/Bio20 [ispe.org] and ISPE.org/ContinuousWrksp [ispe.org]. Support your attendance with a justification letter.   Virtual . ., United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

ISPE Virtual Conf June 1-3

 

 

ISPE-CaSA Members use promo code SAVE15% when registering by 18 May to save 15% on the combined conference and workshop registration.

 

2020 ISPE Biopharmaceutical Manufacturing Virtual Conference [ispe.org], taking place 1–2 June 2020

2020 ISPE Continuous Manufacturing Virtual Workshop [ispe.org], taking place 3–4 June 2020.

What Can You Expect?

  • Fully Loaded Agendas: Between the two events, you'll benefit from topic-focused presentations and panel discussions from 80+ global experts representing FDA, GSK, Kite Pharma, Merck, NIIMBL, Novartis, Roche, Sanofi, and more.
  • Ease of Experience: The event portal is easy to navigate and will allow you to view presentations, participate in Q&A sessions with speakers, plus network and knowledge share with your fellow attendees. The 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference will also feature a virtual exhibitor experience. BONUS: You will receive access to the recording of all conference and workshop sessions for one year.
  • Actionable Insights: Hear from global experts as they share their knowledge and lessons learned on advanced therapeutic medicinal products (ATMPs) such as cell and gene therapies, digitalization, single-use technology, implications of ICH Q12 for biopharma, and much more.


Conference Featured Speakers:

  • Wilson Bryan, MD Director, Office of Tissues and Advanced Therapies, FDA/CBER
  • Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, FDA/CDER
  • Lawrence Hill, PharmD, MBA, CEO, Gan & Lee Pharmaceuticals USA Corp.
  • Carol Lynch, President, US and Head North America, Sandoz US Inc.
  • Maria Hoffman, Executive Director, Engineering, Merck & Co Inc.
  • Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB
  • And More


Workshop Featured Speakers:

  • Rapti Madurawe, PhD, Director, Division of Process Assessment I, FDA/CDER/OPQ
  • Stelios Tsinontides, Director, Office of Pharmaceutical Assessment, FDA
  • Moiz Diwan, PhD, Director, Pharmaceutical Development Research & Development, AbbVie
  • John Erickson, PhD, Senior Fellow, NIIMBL
  • And More

We genuinely believe you will find the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference [ispe.org] and the 2020 ISPE Continuous Manufacturing Virtual Workshop [ispe.org] to be more beneficial now than ever before and will provide you with solutions to critical challenges and information on possible changing of industry norms. 

To explore the complete education agendas and to register, please visit ISPE.org/Bio20 [ispe.org] and ISPE.org/ContinuousWrksp [ispe.org].

Support your attendance with a justification letter.
 

**POSTPONED** ISPE-CaSA YP/Student - Pfizer Sanford Vaccine/Gene Therapy Facility Tour

Event Date
Add to Calendar **POSTPONED** ISPE-CaSA YP/Student - Pfizer Sanford Vaccine/Gene Therapy Facility Tour Pfizer Sanford Vaccine/Gene Therapy Facility Tour for Students & Young Professionals  Update March 13, 2020 : POSTPONED UNTIL FURTHER NOTICE Pfizer Sanford’s manufacturing facility is supporting breakthroughs that change patient’s lives and recently announced the expansion of its gene therapy manufacturing footprint.  This facility is responsible for state-of-the-art gene therapy manufacturing as well as manufacturing components for Pfizer’s vaccine portfolio, including Prevnar 13 and other vaccines in development.  On March 26, students and young professionals are invited to participate in a tour of the facility and learn about the potential impact of gene therapy and vaccines on global health. Due to the capacity limitation for this event the Pfizer site tour is open only for ISPE Student Chapters and Young Professionals with less than 5 years of experience. Here are the details: Date: March 26th, 2020  Time: 9:00 a.m. (carpool to Pfizer mandatory) Carpool Location: 175 Regency Woods Dr, Cary, NC, 27518 Cost: $10 per person includes lunch Event: Tour and presentation 10 a.m. - 12:15 p.m. Lunch: Served at 12:15 Carpooling to the site will be required due to very limited parking. The carpool caravan will leave promptly at 9:10 a.m.   REGISTER HERE MORE DETAILS   175 Regency Woods Dr. Cary, NC 27518 United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

Pfizer Sanford Vaccine/Gene Therapy Facility Tour for Students & Young Professionals 

Update March 13, 2020 : POSTPONED UNTIL FURTHER NOTICE

Pfizer Sanford’s manufacturing facility is supporting breakthroughs that change patient’s lives and recently announced the expansion of its gene therapy manufacturing footprint.  This facility is responsible for state-of-the-art gene therapy manufacturing as well as manufacturing components for Pfizer’s vaccine portfolio, including Prevnar 13 and other vaccines in development.  On March 26, students and young professionals are invited to participate in a tour of the facility and learn about the potential impact of gene therapy and vaccines on global health.

Due to the capacity limitation for this event the Pfizer site tour is open only for ISPE Student Chapters and Young Professionals with less than 5 years of experience.

Here are the details:

Date: March 26th, 2020 

Time: 9:00 a.m. (carpool to Pfizer mandatory)

Carpool Location: 175 Regency Woods Dr, Cary, NC, 27518

Cost: $10 per person includes lunch

Event: Tour and presentation 10 a.m. - 12:15 p.m.

Lunch: Served at 12:15

Carpooling to the site will be required due to very limited parking. The carpool caravan will leave promptly at 9:10 a.m.

 

REGISTER HERE

MORE DETAILS

 

ISPE-CaSA Therapeutic Thursday - Greeneville, SC - February 27, 2020

Event Date
Add to Calendar ISPE-CaSA Therapeutic Thursday - Greeneville, SC - February 27, 2020 JOIN US FOR Therapeutic Thursday February 27, 2020    (rescheduled from February 6 due to storms) 5:30pm to 7:30pm   The Commons 147 Wellburn St., Greenville, South Carolina Thanks to our Sponsor! Jacobs   SPONSOR PROVIDED APPETIZERS with Cash Bar NO REGISTRATION REQUIRED  The Commons 147 Wellburn Street Greenville, SC 29601 United States rcisneros@rickzebradesigns.com America/New_York public
Program Information

JOIN US FOR

Therapeutic Thursday

February 27, 2020   

(rescheduled from February 6 due to storms)

5:30pm to 7:30pm

The Commons

 

The Commons

147 Wellburn St., Greenville, South Carolina

Thanks to our Sponsor!

Jacobs

Jacobs

 

SPONSOR PROVIDED APPETIZERS with Cash Bar

NO REGISTRATION REQUIRED