AAPS launches a new ecourse on regulatory compliance—on demand and available now!
Are you interested in having a better understanding of the regulatory requirements for developing and marketing pharmaceutical products? AAPS’ Regulatory Compliance for Pharmaceutical Scientists ecourse is now available!
This ecourse will provide you with cross-functional training in regulatory affairs designed to help you discover strategies for navigating the rapidly evolving regulatory landscape. It will cover topics such as good laboratory practices, good clinical practice, and current good manufacturing practices. You are not going to want to miss out on this exciting learning opportunity!
Want a course preview? Check out the quiz below for a sample of topics covered. Check your answers below.
1. Which of the following is NOT included during the creation of a regulation?
- Publication of the proposed rule in the Federal Register
- Establishment of a comment period for the proposed rule
- Discussion of the comments received during the comment period
- An available online presentation by the Food and Drug Administration (FDA) explaining the need for the regulation
2. The following statements apply to FDA-issued guidances EXCEPT
- Guidances are the most specific description of FDA’s expectations for industry on a given topic.
- Guidances are not legally binding on FDA or industry.
- Guidances are issued via the notice and comment process.
- Guidances reflect FDA’s “current thinking” on a topic.
3. All reagents and solutions must be
- properly stored
- labeled with the preparation date and initials of the preparer
- labeled with identity
- labeled with titer or concentration
- labeled with storage requirements
- labeled with expiration date
4. Per 21 CFR 211.180(e), how often is the manufacturer expected to evaluate the need for changes to a product
specification, manufacturing process, and controls procedures?
- Every 10 years
- Every 5 years
- Every 3 years
- Every 2 years
- At least annually
5. Quality agreements should include:
- the responsibilities of each party
- assurance of full cGMP conformance
- facilitating consistent delivery of safe and effective medicines
- all of the above
ANSWERS: D, C, B, E, D
To learn more about AAPS ecourses—including an overview, lecture titles, instructors, reviewers, CORE team members, informational brochures, previews of each lecture, and pricing—visit the AAPS ecourse webpage. If you have an idea for an AAPS ecourse or webinar, please submit a proposal online!