Change Control Best Practices - Avoiding Unintended Consequences of Changes

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Category FDA GXP Compliance - Pharmaceuticals;

Deadline: November 03, 2016 | Date: November 03, 2016-November 04, 2016

Venue/Country: Philadelphia, U.S.A

Updated: 2016-10-07 19:24:59 (GMT+9)

Call For Papers - CFP

This seminar will guide all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply the fundamental change control steps and best practices. The key focus will remain on:

Change proposals

Justification / risk assessment

Change execution / implementation

The seminar will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc. Document change control will be discussed as a supporting element. Additionally, this practical, how-to course will illustrate and impart:

The importance of subject matter expertise, proper planning, critical thinking skills, and co-ordination of all change activities.

Skills needed for applying change controls within an organization.

Group exercises to allow participants to practice skill sets with feedback from the instructor.

Practical training by having participant teams complete a full write-up for a mock change control.

Learning Objectives:

On completing this course on FDA compliance, participants will be able to:

Understand regulatory requirements and FDA expectations for change control

Understand the purpose of change control

Identify what types of changes are /are not subject to change control

Properly describe a change

Properly justify a change

Develop a comprehensive change execution plan

Conduct a proper change risk assessment

Accurately execute a change

Accurately implement a change

Develop a full change control package

Utilize critical thinking skills throughout the change control process

Avoid pitfalls during the change control process

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

Topic Background:

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes do not adversely impact products, processes, equipment, facilities, etc. Any individually inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-change-control-expectations-best-practices-seminar-training-80244SEM-prdsm?channel=ourglocal