Developing a Contamination Control Strategy скачать в хорошем качестве

Developing a Contamination Control Strategy

Learn more about contamination control strategies (CCS), how to identify and assess risks, prepare mitigation pathways, and define preventative actions associated with contamination in sterile product manufacturing. Key Learn Objectives: Learn about elements for developing a containment control strategy. Know what to expect from the technical report. Understand practical considerations for containment control strategy. About RCA Regulatory Compliance Associates® (RCA) provides regulatory compliance consulting to the following industries for resolution of compliance and regulatory challenges: Pharmaceutical Biologic & Biotechnology Sterile compounding Medical device Lab Testing We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience. Founded in 2000 Headquartered in Wisconsin (USA) Expertise backed by over 500 industry subject matter experts Acquired by Sotera Health in 2021 About Sotera Health The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year. We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies. To begin the Regulatory Compliance Associates® scoping process today, contact us now. https://www.rcainc.com/contact-us/