The United States Food and Drug Administration (FDA) reviews, clears or approves regulatory applications for drugs, biologics, medical devices including in vitro diagnostic devices (IVDs) and combination products.
It is imperative that firms identify and map evolving regulatory requirements so that regulatory submissions for in particular, combination products, can be better prepared for and managed with awareness in advance.
This seminar is intended to discuss regulatory requirements relevant and applicable to combination products. It is further intended to discuss CGMP requirements for combination products.
The best practices for enforcing a practical, actionable and sustainable regulatory approaches will be discussed, helping to save a significant amount of resources (time, efforts and financial).
In this seminar, the speaker will discuss what firms should consider and address when developing combination products and navigating through FDA’s regulatory pathways.
Areas Covered in the Session :
- Applicable Laws and Regulations
- FDA Guidance
- Regulatory Requirements for Combination Products
- Implementing Compliance to Quality System Regulations
- Implementing Compliance to Drug cGMP Requirements
- Implementing Compliance to With Biological Product and HCT/P Requirements
- Comparative Discussion on 21 CFR Parts 210/211, 600-680, 820, and 1271
- Common Misconceptions
- Adequate Implementation of Regulatory Requirements
- Recent FDA Approvals of Combination Products
- Best Practices: Dos and Don’ts
- Speaker’s PASS-IT Recommendations
Who Will Benefit:
- Compliance Officers
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- Personnel looking for a general understanding of the FDA Combination Product Process