PDA Letter Article

Chair's Message: Busy Week in Dallas Marks Return to Live Events

by Susan Schniepp, PDA Chair 2022-2023

Sue Schniepp

Needless to say, 2020 and 2021 were difficult years. I want to thank our members, Board of Directors and the PDA staff for the loyalty and dedication everyone showed in keeping the organization viable and productive through these trying times. I especially wanted to thank Jette Christensen, Board Chair 2020-2021 for her leadership. She led the organization with dignity, integrity and patience as we learned to navigate through the pandemic.

As we enter 2022, we are pleased to be returning to live meetings starting with the 2022 PDA Annual Meeting being held in Dallas, Texas, April 4-6, at the Hyatt Regency. This Conference will focus on the theme to Level Up: Agility in the New Normal! We will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.

Immediately following this conference there is a two-day Annex 1 workshop at the same facility, April 7-8. The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry.

For those attendees not interested in the Annex 1 workshop, there is a training course being offered on the same days titled Sterile Pharmaceutical Dosage Forms: Basic Principles. During this workshop attendees will gain knowledge of the basic principles of sterile pharmaceutical dosage forms required to improve processes by utilizing effective approaches to process validation and sterility assurance and prepare for regulatory inspections based on current inspection trends for parenteral manufacturing. This introductory two-day training course will address cleanroom design, environmental monitoring and control, sterilization principles, manufacturing unit operations, aseptic filling, dosage form development, packaging and stability requirements, validation of aseptic processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends. Half of the training course content will cover small molecules and the other half will cover biologics.

If that isn’t enough, we are offering a one-day course on April 7 titled Going Deeper than Human Error: Finding More Specific Root Causes to Incidents Involving People. During the training course, participants will be able to explore and use different models that are effective in determining what caused or contributed to the category of human error events. Participants can take these models and tools back to their job to use and share with others. Successful application of these models and tools will contribute to finding better and more creative corrective actions and preventive actions, thereby reducing these often-recurring events. Participants will be asked to read in advance an article about an aviation incident which will be used as one of several case studies and activities.

The final offering in Dallas will be a two-day training course titled Quality and Compliance Management for Virtual Companies. This training course will be held April 7-8. The focus of this course is to help you understand what you need to have in place, what the high-risk areas are, and how best to manage those risks as you grow and bring activities in-house. This training course explains the GMP, GCP and GLP responsibilities of virtual companies or others who predominately outsource GxP-governed activities.

The PDA organization is busy at work on preparing the agendas and identifying speakers for the rest of the years conferences and workshops including the 2022 PDA Virus Conference being held in Brussels, Belgium from June 20-21 and the 2022 PDA Advanced Therapy Medicinal Products Conference also being held in Brussels, Belgium, June 22-23. For the complete agendas for conferences, workshops and training courses being offered for 2022, please go to www.pda.org. We look forward to seeing you in Dallas for our first live events in 2 years.

PDA members have so many options for you to participate besides attending conferences, workshops, and training classes. I would also encourage you to keep track of PDA activities by reading the articles in the PDA Letter. These articles are written by PDA staff, Board Members and PDA members and discuss and offer insight into current issues facing our industry. Another way to keep track of issues and gain current information is to join a PDA Interest Group and attend your PDA Chapter events.

PDA’s success depends on the active involvement of our members, so I encourage you to explore all the activities and options available to you as a member and get involved! I look forward to reconnecting with you in person in Dallas.