MUTAGENIC & NITROSAMINES BLUEPRINT

COURSE SUMMARY:

✅The "Mutagenic & Nitrosamine" course is meticulously designed to address the critical aspects of identifying, controlling, and regulating mutagenic impurities and nitrosamines in pharmaceutical products.

✅This comprehensive course delves into the sources of nitrosamine impurities and presents effective strategies for their control, alongside establishing limits for both existing and new nitrosamine impurities.

✅Participants will gain insights into the necessity of testing for nitrosamines in their products, including the requirements for the Limit of Quantification (LOQ) in testing procedures. The course also explores CPCA to define AI for NDSRIs.

✅Further, it offers a deep dive into the classification of mutagenic impurities, setting limits for these impurities, and discussing significant parameters like TD50 (Tumorigenic Dose 50), Threshold of Toxicological Concern (TTC), and Less Than Lifetime (LTL) that are pivotal in assessing risk and ensuring safety.

✅Targeted at professionals in the pharmaceutical industry, quality assurance, quality control, research & development, and regulatory affairs, the "Mutagenic & Nitrosamine" course equips attendees with the knowledge and tools necessary to manage the risks associated with mutagenic and nitrosamine impurities, ensuring compliance with regulatory standards and safeguarding patient health.

✅CERTIFICATE: Receive a certificate upon successfully finishing this course

✅COURSE DURATION: 724 Minutes (12.06 Hours)

✅LANGUAGE: English

✅SELF PACED LEARNING: Offered as an online course featuring pre-recorded videos and structured for distance learning, this program is available to participants globally.

✅LIFETIME ACCES: You will have lifetime access to the course