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Event Name2016 PDA Workshop: Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision
Event Date(s) Wednesday, October 26, 2016  to Thursday, October 27, 2016
Event Location Hyatt Regency Crystal City
Arlington, Virginia
Cost$280 - $4,449
DescriptionHealth Authorities have signaled their desire to incorporate modern principles of risk management and consideration of new technologies into Current GMPs for sterile manufacturing. It is important for industry to understand requirements, which are often presented differently across regulations and guidelines of various health authorities. The 2016 PDA Workshop: Current Challenges in Aseptic Processing, Potential Changes in EMA/PIC/S Annex 1 Revision will present the experts’ perspective on the points to consider in addressing the most frequent questions raised in the interpretation of applicable regulations for aseptic processing, as well as related recommendations of best practices for sterile product manufacturing.

This Workshop will explore the critical topics within the scope of the new revision of the EU GMP Annex 1, which will impact the global manufacturing of sterile medicines for the next decade or more. Session topics will address the most difficult issues companies are currently facing, based on recent inspections and process performance history.

Hear from experts on a wide range of topics, including environmental monitoring, personnel and material transfer, process simulation, cleaning/disinfection/sterilization practices and critical utilities. The sessions promotes the harmonization of applicable requirements and aim to ensure good science and risk based principles are used in the establishment of new regulations in this area.

Each session is designed to inform and provoke discussion; at the end of each day, a break out session will further explore that day’s discussions.

Learning Objectives

Upon completion of this Workshop, you will be able to:

•Discuss the challenges of aseptically manufacturing healthcare sterile products in a modern, global, technological and regulatory environment

•Interpret the latest regulatory expectations and industry standards for aseptic processing and clean room operation

•Explain the use of risk- and science-based approaches to aseptic process design, validation and monitoring

•Identify best practices for clean room personnel, material decontamination and work flows in the aseptic environment

•Summarize the challenges faced by peers in the aseptic process industry

Who Should Attend

Job Function: Microbiology | Validation | Engineering |Quality | Regulatory | Sterility Assurance | Sterile Operations |Product and Process Development | Operations and Quality | GMP Consultants | GMP Service Providers

Departments: Manufacturing | Formulation | Compliance |Engineering | QA/QC | Process Design | Regulatory Affairs |Research and Development | Technical Operations | Validation
SponsorRebound Therapeutics
Host CompanyParenteral Drug Association
Contact Information Phone: +1-301-656-5900 ext. 132
Fax:   N/A 
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