US Labeling Controls by Rita L.Shahvar
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| Description: | DESCRIPTION The objective of this course is to provide an overview and introduction to the many details that must be considered in the design, preparation, packaging, labeling and distribution of clinical trial label materials; as well as pre-market and post-market labeling for new and already marketed drugs, biologics and medical device labeling. Emphasis will be given to practical examples of procedures, components, and regulatory requirements needed to provide acceptable investigational and commercial materials within the United States. The information presented in this course will consider real-world labeling problems and solutions. Why should you attend : This survey course will emphasize the procedures and techniques needed to prepare compliant pre-market, clinical trial and commercial supplies, in accordance with the local, regional and federal laws. The course is intended for individuals who are new to the product labeling process as well as for those who have experience in commercial drug, biologics and medical device labeling, as well as Clinical Trial Materials (CTM) labeling but want a refresher. This includes, but is not limited to, those involved in: Packaging Labeling Quality Assurance/Control Clinical Manufacturing Regulatory Affairs Research & Development Contract Packaging Areas Covered in the Session: Labeling Requirements of Pharmaceuticals, Biologics and Medical Device in accordance with labeling regulations for 1. Label Concepts 2. Content of Labels 3. Labeling Control a. Bar codes or other electronic labeling b. Mislabeling c. Significant changes/labeling changes 4. “Off-label” and Investigational Use of Marketed Drugs, Biologics and Medical Devices 5. Clinical Trials 6. UDI (Medical Device Only) 7. SPL 8. In-Vitro Diagnostics 9. Product Labeling a. Pre-Market Applications or Licensure b. Advertising and Promotion – Post-Market Who will benefit: (Titles) Packaging Labeling Quality Assurance/Control Clinical Manufacturing Regulatory Affairs Research & Development Contract Packaging Webinar includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 60 Minutes Live Presentation Certificate of attendance For Registration : http://compliance2go.com/product/?topic=export-documentation Note: Use coupon code < T9AIO8AY> and get 15% off on registration. |
| URL: | http://c2gowebinars.com/product/?topic=labeling-controls |
| Date: | Tuesday, March 8, 2016 |
| Time: | 6:00pm-7:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Created by: | Public Access |
| Updated: | Thursday, February 18, 2016 9:24am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | 8777824696 |
| Comments: | None |