Understanding Combination Products: Navigating the Rules and Regulations
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Online Webinar by
Online Compliance Panel
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This training will help you understand what a combination product is, highlight some of the changes in how the FDA views combination products, the approval steps for combination products and proposed regulations for these types of products.
Why Should you Attend
Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and a drug/biologic such that both are combined together and are required to achieve the intended result. The FDA’s Final Rule concerning combination products has been recently published and defines the regulations that apply to the various combinations of combination products. Navigating this rule and the regulations of our global neighbors is a challenge for manufacturers. This webinar is essential for those who are currently manufacturing combination products or anticipating submitting potential products for approval. This webinar will provide the knowledge necessary to determine the regulations that apply to common combination product types. GMPs for combination products will also be discussed in addition to a discussion of the particular challenges facing manufacturers today.
Why Should you Attend
Combination products are the newest and most complicated of products regulated by the FDA and other global regulatory agencies. In general, a combination product is composed of two or more regulated products such as a medical device and a drug/biologic such that both are combined together and are required to achieve the intended result. The FDA’s Final Rule concerning combination products has been recently published and defines the regulations that apply to the various combinations of combination products. Navigating this rule and the regulations of our global neighbors is a challenge for manufacturers. This webinar is essential for those who are currently manufacturing combination products or anticipating submitting potential products for approval. This webinar will provide the knowledge necessary to determine the regulations that apply to common combination product types. GMPs for combination products will also be discussed in addition to a discussion of the particular challenges facing manufacturers today.
Outline
Objectives of the Presentation
- Define the term "Combination Products"
- Identify and explain the US Regulations that pertain to combination products
- Explain the combination product approval process
- Identify and explain the GMPs for combination products
- Combination product examples
- Complexity surrounding combination products
- Combination product regulations
- Combination product approval process
- Combination product cGMPs
- Warning Letter case study review
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Onlinecompliancepanel is a dedicated team of youngsters, who work in tandem with the latest US FDA regulations/regulatory compliance in creating training sessions suitable for individuals and corporations. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and many more. We emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices, risk management and market trends.
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
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