Regulatory expectations, including the use of more effective risk-based decision making, have changed due to the expansion of global manufacturing, the need to produce new therapies and products, and the use of new technologies. As a result, aseptic processing and terminal sterilization practices have been revisited, and the need for more reliable, efficient, and effective product manufacturing, control, and release processes has emerged. The proposed revision to EU Annex 1: Manufacture of Sterile Medicinal Products aims to address these trends.
Over the past decade, Aseptic Processing has increasingly become a prominent method for manufacturing sterile pharmaceutical products. It is the preferred, and in many cases, the only method available for manufacturing many of the new biologic therapies, even as it continues to be the method used for many long-standing more traditional drug products. In addition, there has been renewed interest in the use of terminal sterilization and post-aseptic processing microbiological treatments/sterilization to ensure product quality and sterility.
Health authorities from around the world are tightening expectations for sterile product quality and safety, based on patient risk. Producers of sterile products are contemplating true risk-based approaches to improve manufacturing and manufacturing controls to better meet challenges and comply with regulatory requirements. The need for dialogue and partnership between manufacturers, suppliers, and regulators is growing as a means to solve issues and improve.
The 2018 PDA Sterile Medicinal Products Manufacturing Conference will bring together sterile product experts and the sterile products community to highlight contemporary approaches for sterile product manufacturing. This will be done using case studies and personal experiences from recognized industry and regulatory agency experts. The Conference will cover modern approaches to aseptic product manufacturing and will focus on the following sterile product manufacturing essentials, with special reference to the draft revision of the EU GMP Annex 1:
- Risk- and science-based assessment and approaches in sterile product facility design and manufacturing processes – what works and what may not be worth the risk
- Modern methods for cleanroom qualification, environmental monitoring, and contamination control
- How to better use existing sterile product technologies
- PDA and industry responses to the proposed revision to Annex 1 and other regulatory trends and expectations
- New thinking on sterile product manufacturing validation and process simulation
Learning Objectives
At the completion of this Conference, the participant will be prepared to better understand and meet the challenges of manufacturing healthcare sterile products in a modern global technological and regulatory environment by:
- Explaining the latest methods for sterile product manufacturing risk evaluation
- Describing the benefits associated with post-aseptic processing microbiological treatments/sterilization
- Interpreting regulatory risk perspectives and implications for sterile product manufacturing and processing
- Identifying contemporary aseptic processing technologies for risk minimization
- Recognizing the new requirements present in the draft revised Annex 1
Who Should Attend
Department
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Research and Development | Technical Operations | Validation
Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor
Job Function
Microbiology | Validation | Engineering | Quality | Regulatory | Sterility Assurance | Sterile Operations | Product and Process Development
Conference Inquiries
Brooke Schneider, CMP
Manager, Programs
Tel: +1 (301) 656-5900 ext. 111
Email: [email protected]
Registration Inquiries
Tel: +1 (301) 656-5900 ext. 115
Email: [email protected]
Exhibition/Sponsorship Inquiries
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
Email: [email protected]