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PDA Southeast Chapter

Crystal Booth

President: Crystal Booth

PSC Biotech


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 2021 Sponsors!

Platinum Sponsors

  • Ecolab
  • Microbiologics
  • Steris
  • Biotech

Silver Sponsors

Gold Sponsors

Annual Webinar Sponsor


Upcoming Chapter Events

Coming Soon

PDA Signature Events



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.

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.

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.

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.

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.

Jessica Blomberg

Jessica Blomberg
Quality CMC Consulting

Jessica Blomberg owns Quality CMC Consulting, a pharmaceutical development consulting company, focusing on delivering flexible and phase appropriate support to emerging and established Biotech/Pharma/Medical device clients, and empowering compliant and science driven decisions that are right first time. She assists clients with due diligence M&A activities and virtual company design and function. She was named 2020 Triangle Business Journal Life Science Consultant of the Year. Selected clients include Chiesi USA, HemoShear Therapeutics, Icosavax, Locus Biosciences, Notable Labs, Roivant, and Activated Research Company as a strategic advisor. Prior to starting Quality CMC Consulting in Dec-2012, she worked for small-to-mid sized companies in RTP, NC: Erimos (Pharmaceutical Development), Inspire (Sterile Manufacturing) and BioCryst (QA). During this time for seven years, she was on the executive committee serving as Past-Chair, Chair, Co-Chair, Secretary, and Treasurer for the non-profit NC Discussion Group of AAPS. Jessica received her Ph.D. in Analytical Chemistry from Duke University in 2003, is a Board Member of the Astronaut Scholarship Foundation, and a PDA member since 2012. She is the co-inventor of multiple patents and provides training to the industry.

Networking Chair
Casey Poirier

Casey Poirier
STERIS Corporation

Casey Bailey Poirier is a North Carolina native and an Account Manager with STERIS Corporation Life Sciences Division. Her current responsibilities include providing contamination control solutions related to disinfection, process cleaning, and sterility assurance for the biotech, pharmaceutical, and medical device industries. Casey leverages over 12 years of experience in QC Chemistry, QC Microbiology, and Validation roles. Prior to joining STERIS, she served as a Lead Validation Engineer for Stallergenes Greer where she oversaw the site process simulation program, led projects to continuously improve validation and quality system programs, and enhance equipment performance capabilities. During her tenure as a validation professional, she became well versed with PDA Technical Reports as a guideline for compliance during these initiatives. She earned a Bachelor of Science in Biology at Wingate University and Master of Business Administration in Project Management. In addition, she holds Lean Six Sigma Green Belt Certification from University of North Carolina at Charlotte.


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,  and MS.

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, schedules, 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.





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.



Attention PDA Southeast Student Chapter Members

Are you passionate and excited about your chosen career in the pharmaceutical or biotechnology industry? If so, what aspect of the pharmaceutical or biotechnology industry interests you most, and why?

PDASE and Kymanox are offering a $2,500 scholarship for Engineering or Science related majors for the academic year 2020-2021. To apply, complete the scholarship application at, including a 500-750 word essay and submit your (unofficial) transcript by August 15, 2020.

Applicants must:

  • Have a current PDA membership
  • Be in good standing at your academic institution with a GPA of 3.0 or higher
  • Have a valid social security number
  • Attend a college or university in NC, SC, VA, TN, GA, FL, KY, AL, LA, MS or AR

Questions can also be directed to [email protected].


Chapter Resources

Chapter By-Laws
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