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PDA Southeast Chapter

Crystal Booth

President:Crystal Booth

PSC Biotech

Overview

The Parenteral Drug Association's Southeast Chapter (PDASE) is proud to encourage a cooperative spirit among the medical, pharmaceutical, and clinical professions. PDASE aims to foster and advance the art and science of pharmaceuticals, medical devices, and biotechnology. As part of that effort, we especially encourage cooperative spirit among PDASE members and professionals in these fields.

PDASE provides and disseminates information relating to technology in the pharmaceutical, medical device, biotechnology, and clinical industries by promoting high manufacturing standards and encourages the sharing of scientific and technical knowledge.

 

Thank You to our 2019 Sponsors!

Platinum Sponsors

  • Aramark
  • kymanox

Silver Sponsors

Gold Sponsors

  • AzzurGoup
  • Contec
  • Masy BioServices
  • CAI
  • Fluor
  • Gills Process Control
  • Microbiologics
  • PharmaSys
 

Upcoming Chapter Events

 

PDA Signature Events

 

Officers

President
Crystal Booth

Crystal Booth
PSC Biotech

Crystal Booth earned a Master's in Microbiology and had 19 years of experience in the industry. She has worked for various companies in Consulting, QA, QC, and R&D Microbiology. Crystal has worked with regulatory bodies, developed and validated methods, equipment, EM, and utility programs. Crystal is the author of the "Method Development and Validation for the Pharmaceutical Microbiologist." Based on her work on the publication, Crystal earned the 2017 Distinguished Editor/Author Award.

President-Elect
Kenneth Boone

Kenneth Boone 
Merck & Company, Inc.

Ken Boone is a Director of Sterile and Microbiology Quality Assurance within the Global Compliance group at Merck. His current responsibilities include sterility assurance and aseptic processing for Merck sites globally that produce sterile and low bioburden products and to ensure sites' compliance with current regulatory guidelines and expectations. Before Merck, Ken had a variety of global and site-based microbiology, aseptic processing, and sterility assurance responsibilities for Novartis, Mallinckrodt, Cardinal Health, and Pfizer. He has been a member of PDA since 2002 and is a founding member of the Missouri Valley Chapter of the PDA and its former President-elect. Ken has presented at two recent PDA Conferences on the challenges posed by anaerobic organisms to aseptic production and is a co-author on a manuscript accepted for publication in the PDA Journal of Pharmaceutical Science and Technology. He is a graduate of the University of Kansas.

Secretary
Amanda Bishop McFarland

Amanda Bishop McFarland, M.S.
Valsource, LLC

Amanda Bishop McFarland, M.S. is a Quality Risk Management and Microbiology Senior Consultant with Valsource, LLC with over 15 years of industry experience. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Before joining ValSource, Amanda worked to integrate a global risk management program within a multi-national company by developing the procedures required and training the organization in the execution of consistent risk management tools. Amanda currently serves as the co-lead of the PDA Quality Risk Management Interest Group and is a faculty member of the PDA's Quality Risk Management courses. On behalf of the PDA, she developed and delivers training for QRM Foundations, QRM for Decision Makers, and Risk Facilitation Skills. Amanda has a Bachelor of Science (Entomology) and a Masters Degree in Mycology both from the University of Florida.

Treasurer
Gwen Lohr

Gwen Lohr
Novo Nordisk

Gwen Lohr has more than 20 years of experience in the pharmaceutical industry. She has held various management roles and is currently the Regulatory and Compliance Specialist for Novo Nordisk Pharmaceuticals. Gwen has a comprehensive knowledge of inspection and compliance for Aseptic Processing, laboratory, finished product production, and batch release. She is a Certified Quality Auditor and has been an active member of the PDASE chapter for more than ten years.

Member-at-Large
David Yaffe

David Yaffe
Commissioning Agents, Inc.

David is a Project Manager at Commissioning Agents, Inc. with over 35 years of professional experience. His responsibilities include staff training and development, regional talent acquisition, marketing/sales support, and serves on the President's Advisory Committee. He executes many projects in a range of areas including maintenance and reliability engineering, quality risk management, C&Q program implementation, and risk-based validation programs. Mr. Yaffe is currently serving as the Chair of the PDA SE Chapter Event Coordination Committee and has attended many local PDA events over the years. He served on the Carolina South Atlantic Chapter of the ISPE as the Programs Committee Chair and the Board of Directors for two years. Mr. Yaffe is a retired naval nuclear submarine Chief Petty Officer who served for 20 years. Mr. Yaffe earned a Bachelors of Science degree in Human Resources Management from the New School for Social Research, NY, NY and is a Certified Pharmaceutical Industry Professional.

 

About Us

PDASE's Executive Board and Committee chairs consist of professionals in the biotech, pharmaceutical, medical device, and clinical industries. The Executive Board works with Committee Heads to deliver events and collaboration with industry. The Southeast Chapter's region covers eleven states including NC, SC, VA, TN, GA, FL, KY, AL, LA, MS, and AR.

Events are held throughout the region to support PDA's mission of Connecting People, Science and Regulation. Events include Dinner & Dialogue's, Facility Tours, Full-Day Conferences, and Networking Events. PDASE also supports its Student Chapters by offering a Student Scholarship each year.

 

Get Involved

Membership Committee
  • Develops strategy for increasing local chapter membership
    • Outreach to expiring members
    • Local Chapter signups at events
    • Communication at National events about the local chapter
    • Manage the PDA table at Chapter conferences
Approximate Time Commitment

Four to eight hours per month.

Programs Committee
  • Organizes and executes major PDASE events.
  • Engages with FDA, Industry and other regulatory authorities to speak at conferences
  • Develop themes for each conference based on industry feedback
    • Spring Conference
    • Fall Conference
Approximate Time Commitment

Twenty to Forty hours per event the committee member leads (Likely to include all events)

 
Student Outreach Committee
  • Supports student chapters at local Universities
    • Provide chapter updates to PDA for inclusion in the PDA Letter.
    • Develops/Delivers scholarship programs
    • Evaluates feedback from students and faculty
    • Plans specific events for students
      • Facility Tours
      • Speakers from the Industry
      • Meet the Professionals Night
Approximate Time Commitment

Four to eight hours per month.

Networking/Events Committee
  • Provides full event support (planning, scheduling, coordinating, and support monthly events for the local chater
    • Monthly Networking
    • Dinner & Dialogue Events
    • Facility Tour
    • Planning Session
  • Collaborate with Chapter liasions to promote events for the PDASE Chapter
Approximate Time Commitment

Eight to ten hours per month. Additional time commitment is required at the planning session and the beginning of the year.

 
Communications Committee
  • Develops and delivers local PDA communications including:
    • The PDASE Newsletter
    • Upcoming PDASE Event Calendar
  • Writes articles for local and national activities within PDA
  • Manage social media websites
    • LinkedIn
    • PDA Southeast Chapter Connect Page
Approximate Time Commitment

Four to eight hours per week.

Chapter Outreach Committee
  • Plans, schedulees, coordinates, and supports monthly events for the local chater
    • Monthly Networking
    • Dinner & Dialogue Events
    • Facility Tour
  • Collaborate with Chapter liasions to promote events for the PDASE Chapter
Approximate Time Commitment

Eight to ten hours per month. Additional time commitment is required at the planning session and the beginning of the year.

 

Presentations

 

Sponsorship

PDASE has seen our Chapter grow in membership and member engaagement. PDASE is grateful to its dedicated members and sponsors for their continued interest, participation and support. Without sponsorships, PDASE would not be able to offer multiple, inexpensive events for its members. There are many benefits and savings to considering sponsorship of PDASE.

The Sponsorship Form is below.

For additional sponsorship information please contact:

Blue Star Services
5201 Albermarle Drive
Oriental, NC 28571
Telephone: 919.418.1325
Fax: 919.933.9233
[email protected]

PDASE appreciates your consideration to support the Chapter.

 

Chapter Resources

Chapter By-Laws

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