Regulatory Affairs Training
Regulatory Affairs training can help your team learn about the drug approval process and the differences between CDER and CBER and FDA and EMA regulations.
Our training programs can be customized to meet your company’s specific needs. We can create a customized agenda from our listed topics below or we can incorporate other relevant topics that you request.
Examples of 483s, Warning Letters or other official action will be included, as appropriate.
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Regulatory Affairs Topics
- Regulatory Affairs training can help your team learn about the drug approval process and the differences between CDER and CBER and FDA and EMA regulations.
- Our training programs can be customized to meet your company’s specific needs. We can create a customized agenda from our listed topics below or we can incorporate other relevant topics that you request.
- Examples of 483s, Warning Letters or other official action will be included, as appropriate.
- Introduction to GMPs
- US vs EU GMPs
- FDA's systems and risk-based inspections
- International/EU GMPs including ICH guidelines
- Quality Agreements
- CAPAs
- Change control
- Deviations
- Training
- Regulatory Sanctions: FDA , MHRA, EU
- How do CDER and CBER differ for submissions and inspections?
- What is a BLA and what are the expectations of the FDA for a BLA submission?
- Differences between a BLA and an NDA submission
- The differences between MHRA and EMA
- FDA vs. EU regulations and guidelines
- FDA vs. MHRA inspections and inspectional initiatives