Effective Systems for Change Control in the Pharmaceutical Industry

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

David L Chesney
Principal and General Manager, DL Chesney Consulting LLC

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC. His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.

Until recently, he served as Vice President, Strategic Compliance Services for PAREXEL Consulting, a business unit of PAREXEL International LLC. Prior to joining PAREXEL Consulting in 1995, Mr. Chesney served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. For 19 years, he led the Strategic Compliance Consulting group, and also personally provided regulatory enforcement related consulting services to the pharmaceutical, medical device and biologics industries, plus technical assistance to legal counsel in FDA regulatory matters. Mr. Chesney has a bachelor's degree and postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.

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