Change Control Under the cGMPs and How the Regulations are Changing

Instructor: Peter Calcott
Product ID: 702104
  • Duration: 90 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This webinar on change control will discuss how to interpret the cGMP regulations with respect to the present climate of requirements and will look into the future to assure that the system you implement will be acceptable to the regulators and your business requirements in the future.

Why Should You Attend:

This webinar will provide valuable information on the requirements of an effective change control process from an operational and regulatory perspective. It will describe how and when to implement a system that is both cost effective and compliant, in an ever-changing regulatory landscape, keeping appropriate control over the processes and products without burdening the business.

These tiered, risk based processes, discusses in this training, will allow low risk changes to be implemented quickly and simply yet exert appropriate checks and controls on those which can have high impact on your operational success and your regulatory standing. These tiered systems allow you to rapidly change your strategy when regulatory requirements change. We will include models of systems that will allow you to benchmark your processes to determine whether they are as robust and efficient as you believe. Examples of where companies failed to live up to the regulatory agency expectations will be presented that enable you to see what exactly the agencies are looking for and why.

Areas Covered in the Seminar:

  • Reasons for a robust change control process and the key elements of one.
  • When the process should be implemented to add the greatest value and least burden on operations especially in commissioning a new plant?
  • How to set up a tiered, risk based system to control at the right level and not over manage or stifle operations.
  • Why agencies come down on some companies for deficient change processes so you will avoid these traps and pass muster with these agencies?
  • Why separating document from product/process change control is important?
  • The value of a multidisciplinary change control committee to manage your operational changes.
  • Who must review and approve changes and when to get Regulatory Affairs involved in the process?
  • How to implement a change control process into the IT function - a formidable task?
  • To manage change at a distance with contract manufacturers.

Who Will Benefit:

This Webinar is useful for all companies in pharmaceutical and biotech industries. All staff from following department must attend this course

  • Senior management and executives
  • Quality Assurance and Compliance
  • Quality Control
  • Regulatory Affairs
  • Manufacturing
  • Validation
  • Supply Chain and Logistics
  • Project Managers working in the CMC arena
  • Engineering
  • IT working in regulated areas
  • Drug Safety
  • Process Development

Instructor Profile:

Peter Calcott, Ph.D. is founder and President of Calcott Consulting which serves the biotech, pharma and venture capital industry. It provides consulting services in supply chain, quality systems, clinical development, regulatory affairs, compliance and governance, enterprise e-solutions and government affairs. It also provides corporate strategy development, analysis and assessment especially due diligence evaluation.

He has held positions in industry in all these disciplines over a 30 year career. He has presented at national meetings and is active in the biotechnology community via BIO and the bay area BayBio trade associations where he has been the chairman of the BIO RAC committee and is presently a Board member of BayBio.

Topic Background:

Regulations in all markets require that you operate your manufacturing and quality systems as described in your license and within prescribed standards of GMP.  In order to change your established processes and operations requires that you examine the proposed change to assure it does not negatively impact your product or pose added risk to the patient.

This process to regulate change, change control, is required and defined in regulatory documents including ICH Q7A.  However, the processes implemented in many operations while meeting the regulatory requirements are not necessarily as efficient or robust as they can be.  While regulations do allow you to develop tiered processes tied to the risk of the change, many companies do not establish a system that utilizes all these elements which results in either lax, non compliant or rigid, draconian processes, each of which poses risk to the proponents. To make the situation more complex, regulations are changing especially as FDA implements their “GMP's in the 21st century”.  In the warning letters issued in 2009 through 2011, it is clear that companies are still laboring to establish compliant systems that meet these new paradigms in the regulatory world.

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