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Feb 02


EFFECTIVE SYSTEMS FOR CHANGE CONTROL IN THE PHARMACEUTICAL INDUSTRY

This webinar will help you understand GMP requirements for change control from a
pharmaceutical manufacturing perspective

By Comply Rules
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120 followers


WHEN AND WHERE


DATE AND TIME

Thu, February 2, 2023, 3:00 PM – 4:30 PM EST


LOCATION

Online


REFUND POLICY

Contact the organizer to request a refund.


ABOUT THIS EVENT

 * 1 hour 30 minutes
 * Mobile eTicket

Date: Feb 2, 2023



Time: 3 PM EST



Duration: 90 Mins



Level: Intermediate to Advanced



Group Packages: Please contact ben@complyrules.com

This webinar will help you understand GMP requirements for change control from a
pharmaceutical manufacturing perspective, the purpose of change control and what
types of changes are or are not subject to change control. Participants will
learn how to execute and implement a change in a regulated environment.

Why Should You Attend:

Change control is a complex but very important aspect of GMP compliance. Many
companies struggle with inefficient and overly complicated systems that are
paper and time-intensive due to a lack of solid understanding of the purpose of
change control and the methods that can be employed to make it more efficient.
This webinar explains the purpose of change control and what works best to
implement it in a GMP-governed setting.

Learning Objectives

 * Understand the purpose of change control
 * Learn where the requirement is listed in the GMP regulations
 * Learn how to make the change control process more efficient
 * Understand the importance of compliance with regulatory submission
   requirements related to change and the role of Regulatory Affairs in the
   change control process

Areas Covered in the Webinar:

 * Purpose of change control
 * GMP requirement for change control
 * Change control in commercial versus investigational product manufacturing
 * Points to consider for change control SOPs
 * Levels of change and what is not a “change”
 * Considerations for regulatory submissions related to changes
 * Annual report
 * Changes Being Effected
 * Changes Being Effected/30 days
 * Prior Approval changes

Who Will Benefit:

This course is designed from a pharmaceutical manufacturing perspective;
however, since the main focus is on techniques and practices, the course
material may be equally applied to biologics and medical device environments. It
will benefit:

 * Change proposal authors
 * Reviewers / approvers of change controls
 * Change control system owners
 * Production staff / management
 * Engineering staff / management
 * Validation staff /management
 * QA and QC staff / management
 * Regulatory affairs staff / management

Additional service: (Personalized session)

We also do various similar customized events for our clients and it is specially
tailored as per the client's requirement. We arrange calls between clients and
our course instructors to better understand the training requirement and
accordingly a training program is designed. The course duration ranges between
90 Mins and 12 hours. Most 6 hours and 12 hours of classes are split into 2 to 3
days considering customer convenience.

We have 500+ consultants who are associated with us and each have their own
specialization example GxP, GMP,GLP, 21 CFR, Computer system validation, FDA
Audit & Inspection, Bioassays, Design Control, Data Integrity, FDA regulation,
Clinical compliance, and almost everything that falls under Risk, Quality and
Compliance arena in the Life Science industry.

If you think that your team needs some kind of boost, update or refresher in
Risk management and Regulatory compliance then let me know and we can design a
highly cost efficient program for you.


TAGS

 * Online Events
 * Online Classes
 * Online Science & Tech Classes


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COMPLY RULES

Organizer of Effective Systems for Change Control in the Pharmaceutical Industry



Facebook profileOrganizer website
 * Follow
 * Contact

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$249
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