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Home ›FDA Compliance ›  Drug and Device Approvals

FDA Drug and Device Approvals Training, Compliance Best Practices and Standards

Drug and device approval processes and requirements training through webinars, in-person seminars, standards and best practices. Learn from renowned experts about getting regulatory approval for drugs and medical devices - Drug Approval Process, Premarket Notification, 510(k), Premarket Approval (PMA), New Device Approvals, PMA CDRH, PMA CBER, 510(k) CDRH, 510(k) CBER, etc.
Sub Categories: Risk Management | Packaging and Labeling | FDA Audit and Inspection | Drug and Device Approvals | FDA Validation | FDA 21 CFR Part 11 | Marketing and Promotion | Documentation and IT | Quality and Safety | Regulations & Guidances | Best Practices & GXPs
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Recorded/CD
Classifying Medical Devices - US and EU

Classifying Medical Devices - US and EU

  • Speaker: Charles H Paul
  • Product ID: 705045
  • Duration: 60 Min
The Medical Device Classification webinar explains the classification system in US and the EU.
CD/Recorded
$219
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Recorded/CD
Drug Pharmacy Compounding

Drug Pharmacy Compounding

  • Speaker: Rachelle D Souza
  • Product ID: 704907
  • Duration: 60 Min
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
CD/Recorded
$249
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Recorded/CD
Preparing Stability Protocols for Development and Commercial Products

Preparing Stability Protocols for Development and Commercial Products

  • Speaker: Peggy Berry
  • Product ID: 704459
  • Duration: 90 Min
This training program will discuss the requirements of ICH and the FDA for stability protocol content and format, including special stability studies required for approval.
CD/Recorded
$279
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Recorded/CD
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries

  • Speaker: Rossano V Gerald
  • Product ID: 705186
  • Duration: 60 Min
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
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