Thursday April 5, 2018
1:30 pm – 3:00 pm EDT
Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)
Biotechnology/Pharmaceutical/Microbiological Urban Myths have created a very interesting landscape for many years. As personnel turnover continues to occur within the pharmaceutical/biotechnology arena, these Urban Myths again are thriving. Often the term that one hears is “standard industry practices” – but what does it mean? Does this infer that the “practices” are sanctioned by the government or industry?
In addition, many misunderstandings occur within USP, EP, FDA Guidances, and other governmental/regulatory documents that have were issued years ago. In some instances, a recent change that was made within a USP Chapter or FDA Guidance creates a misunderstanding because of a long history of the original document and a lack of knowledge of where their contents originated.
This live, interactive webinar will review many of the issues surrounding Urban Myths to allow for a more ready understanding of “fact vs. fiction” as well as to illustrate some of the difficulties associated with “breaking the mold” where industry is involved. Bring your own Urban Myths to this webinar to permit discussion by the entire audience.
You may also find that by bringing a multidisciplinary group to this webinar, you will gain the greatest benefit.
By attending, you will learn:
- Urban Myths vs. Reality of Biotechnology/Pharmaceutical/ Microbiological standard industry practices
- Discuss “Standard Industry Practice” vs. What Actually Occurs in Industry. What causes a “Standard Industry Practice” to change?
- Resources: USP, USP Guidance Documents, Regulations (U.S., European, Japan, others) – Even they may have flaws
- Interpretation: Fact vs. Fiction – Even within USP
- Changes vs. Time – Even Microbiologists can Change Their Minds
- ICH Q9 Quality Risk Management – It’s Role in Urban Myths
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-020