Bye Bye to the Five Whys?!

2/13/19

Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the five whys. But if you have used the 5 Whys before, have you noticed that you are not confident in the results? There is a better solution to getting to root cause in a more reproducible way, to developing actions and implementing them.

Rare Diseases: Comment Period Now Open for Revised Draft (Update)

2/12/2019

The Food and Drug Administration (FDA) has revised the draft guidance, “Rare Diseases: Common Issues in Drug Development Guidance for Industry”. The original draft guidance was issued August 2015. The revised draft guidance was published in the Federal Register February 1, 2019. Our previous blog mentioned that although it was available for public review January 16, there was a delay in publication and comment availability.

ICH E6 Addendum R2 Team Training and Action Planning: February 21, 2019 Webinar

2/08/2019

Topic: ICH E6 Addendum R2 Team Training and Action Planning

Date: February 21, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11: February 14, 2019 Webinar

1/29/2019

Topic: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11

Date: February 14, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.