Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile […]
A risk-based environmental monitoring is a critical component for effective cleaning and disinfection programs. This virtual seminar outlines risk-based program development and implementation; data trending and analysis; and HVAC systems design and validation to ensure your facility is in a state of control. Don’t’ miss industry’s EM leading experts, Ziva Abraham of Microrite, Sheba Zaman […]
Join us as we discuss four different ways of using the process risk control strategy to determine EM sampling.Part 1 – Holistic Process Risk Control Strategy• Process Risk Assessment and establishing a holistic riskcontrol strategy• Environmental risks and risk controlsPart 2 – Environmental CQAs and CPPs• Environmental CPPs and the product CQAs impacted• ISO classifications […]
There is no doubting the impact that 2020 has had on our industry, our country, and our world. With more than 700 therapeutics in the pipeline for COVID-19 alone, speed-to-clinic is a top priority for early-phase manufacturers. There are myriad considerations when transitioning from the lab to clinical operations, specifically for emerging industries such as […]
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