The No. 1 Trade Show Site in the U.S.

Menu
×
EVENT DATE
Oct 2016
M T W T F S S
10111213141516
EXPO DATE
Oct 2016
M T W T F S S
10111213141516

Venue


Online Event
Location map
Tel:
Type: Online Event

HOTEL DEALS

Booking.com

TRAVEL DEALS

Expedia.com

Partners

exhibitus success by design Remington Hotels

Phase I GMPs - By Compliance Global Inc.

B2B

EVENT DESCRIPTION

Overview:

Early clinical trial phases are conducted to establish initial safety of a drug. The drug trial studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.

In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has allowed early stage investigational products to be manufactured under less stringent GMP guidelines.

Why Should You Attend:

This webinar will review the current regulations, guidance documents for early stage manufacturing and GMPs 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 in this Webinar:

• FDA regulations and Guidance Documents for Phase I clinical trials

• Key elements and Best practices of GMP for Phase I clinical trials

• IND content and format for CMC information

• Vendor selection and management for outsourcing early manufacturing

• Raw material selections and considerations

Learning Objectives:

• Understand the differences permitted for phase I GMP compliance regulations

• Ensure that all of the right systems and procedures are in place

Who Will Benefit:

• Directors

• Managers/Supervisors

• Regulatory Affairs

• Manufacturing

• Quality Assurance and Clinical Operations

Speaker 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).

For more detail please click on this below link:

http://bit.ly/2azUh3w

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Contact the event managers listed below for more information about how you can participate at the Phase I GMPs - By Compliance Global Inc..

EVENT CONTACTS

Sign Up for FREE Membership and Log In to access Event Contact Information.

EVENT DETAILS

Primary Industry:
Clinical Pharmacology
Other Industries:
Clinical Pharmacology, Professional Healthcare
Audience:
Directors

Managers/Supervisors

Regulatory Affairs

Manufacturing

Quality Assurance and Clinical Operations
Notes:
Show Owner:
Compliance Global Inc.
Sponsorship: Yes

Exhibitor Information +

Booth Details:

Booth Size
Booth Cost
No Exhibiting
Amenities
Electricity:
n/a
Water:
n/a
Generator:
n/a
Marketing Vehicles Allowed:
n/a
Services
n/a
Show Owner
Compliance Global Inc.

floor plan

MORE events +

BUSINESS+
HEALTH CARE+
MANUFACTURING+
TECHNOLOGY+

Display Makers

Promo Makers

2017: 2,575 Trade Shows
2018: 575 Trade Shows
© copyright since 2008 All Rights Reserved eventsinamerica.com
493
page views