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Containment - Understanding Why, When, and What Regulatory Agencies Expect | For10 years - the Risk Based Manufacture of Pharmaceutical Products has defined expectations for cross contamination control to protect patients. Understand what cross contamination control: why it is needed, when it is needed, how to determine the extent of what is needed, and what the regulatory environment is regarding cross contamination control to protect patients. This protection translates into requirements to also protect operators.
Process Safety | Robust and safe processes are the foundation of pharmaceutical manufacturing. Changes to processes are inevitable, but often result in increased risks…
H2O2: Not the Same Old Topic | H2O2 decontamination has evolved over the years. As aseptic processing has progressed within isolators and within operating rooms, H2O2 has evolved to be used not only as equipment decontamination but also as room decontamination…
Devices and Decontamination—Overcoming Challenges | Aseptic products are oftentimes a component part of a Combination Product. These aseptically filled present technical challenges that will be addressed in this session. Additionally, manufacturers are often tasked with utilizing legacy equipment…
Regulatory and Industry Panel | The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time…