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Event Manager
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

Why should you Attend:
In today's strict regulatory environment it is more important than ever for companies and individuals to understand and practice good documentation to comply with FDA regulatory requirements. This webinar will cover Good Documentation Practice for GxP environments. Understand what needs to be documented, what FDA looks for in documentation, relevant regulations for documentation, and related guidances.

Areas Covered in the Session:
FDA 101: who is the FDA, regulations, guidances, documentation and industry
Why document?
What needs to be documented?
What documentation does FDA look for during an inspection?
What do the GMP, GCP, and GLP regulations and guidances say about documentation?
Examples and exercises for good documentation
Summary/ Q&A

Who Will Benefit:
GxP personnel involved with GxP Documentation

Speaker Profile:
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Event Link :
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There may be many networking opportunities at the Online Webinar on Good Documentation Practice for GxP Environments in September. Find out more in the event details below.

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Event Details

Conference/Event Dates: 09/15/2016 - 09/15/2016
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Education Events
Other Industries: Education, Education Events
Cost to Attend: One Dial-in One Attendee Price: US$150.00
Audience: One Dial-in One Attendee

Price: US$150.00
Number of Exhibitors:1

Booth Details

Booth Size Booth Cost   Available Amenities
Please Contact Compliance4all for Information   Electricity: n/a
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  Marketing Vehicles Allowed: n/a
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Online Webinar on Good Documentation Practice for GxP Environments in September

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