FDA's GMP Expectations for Phase I and First-In-Man Clinical Trials

  • Speaker:Peggy J. Berry
  • Date: 18th December 2017 10:00 AM PST | 01:00 PM EST
  • Duration:75Min
  • Product Code:GRC-90203

$179

refer

Refer Friend's


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve.
  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More about our products contact +1- 248-233-2049)

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 

Why you should attend:

Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development.  Explore and discuss ways to develop and implement strategies for your GMP documentation.

What is the topic about:

This webinar will review the current regulations, guidance documents for GMP Documentation in detail.  Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Areas covered:

  • IND and NDA content and format for CMC information
  • Vendor selection and management for outsourcing early manufacturing
  • Raw material selections and considerations
  • Required SOPs and documentation

Who will benefit:

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance
  • Clinical Operations

Instructor Profile:

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development.  She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.  Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).  She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992).  In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.  She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Available Options

Live Meeting Access: Attend the meeting Live via Webex

$179

Recording: Access it for 6 months from any location

$239

CD: Shipped within 2 working days

$339

Live + Recording: Attend Live + Access the recording for 6 months

$269

5 Member Group: Access the Live Meeting online from any location globally

$649

10 Member group: Access the Live Meeting online from any location globally

$1,229

Live + CD: Attend Live + Get a copy of the CD of the webinar

$379
For discounts and offers call support

Related Products

Root Cause Analysis and CAPA

Root Cause Analysis and CAPA

We offer face to face and online training. If you have 5 or more people interested in learning this topic. Contact our support to set up a date. Description: Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from an industry expert with over 30 years’ experience. You will learn how to get permanent resolution to your seri..

$249

Comparing GLP with GMP

Comparing GLP with GMP

Description:Good Laboratory and Good Manufacturing practices are regulations that are applied during different lifecycle phases of drugs and drug substances. Both regulations have some common requirements but there are also significant differences. There are many  questions about the differences and similarities between both of them and when and how exactly to apply one or the other and how Good Clinical Practice regulations (GCPs) fit between GLP and GMP. This seminar will have all the ans..

$249