Change Control Best Practices - Avoiding Unintended Consequences of Changes: 2-Day In-Person Seminar (Boston, MA - June 26-27, 2018) - ResearchAndMarkets.com

DUBLIN--()--The "Change Control Best Practices - Avoiding Unintended Consequences of Changes: 2-Day In-Person Seminar" conference has been added to ResearchAndMarkets.com's offering.

With FDA citing inadequate change control constantly in its 483s and Warning Letters, the prerequisite to ensure that changes are accurately described, justified, assessed for risk, implemented, and documented has come to the fore. Changes must also be prospectively reviewed by appropriate subject matter experts. Furthermore, certain major changes (e.g. manufacturing, specifications) may require regulatory filings and/or prior regulatory approval.

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:

Seminar Fee Includes:

  • Lunch
  • AM-PM Tea/Coffee
  • Seminar Material
  • USB with seminar presentation
  • Hard copy of presentation
  • Attendance Certificate
  • $100 Gift Cert for next seminar
  • Download Brochure

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

Agenda:

1. Regulatory Requirements

2. FDA Change Control Expectations / Warning Letter Examples

3. Purpose of Change Controls

4. Change Control Process Model

5. Types of Changes Subject to Change Control

6. Change Proposal

7. Change Justification

8. Change Execution Plan

9. Change Proposal Assessment

10. Executing the Change

11. Implementing the Change

12. Change Control Documentation

13. Putting It All Together: A System Viewpoint

14. Change Control Workshop

For more information about this conference visit https://www.researchandmarkets.com/research/xvx47z/change_control?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Finance

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Finance