The presentation will explain the need and implementation of a pharmaceutical manufacturing external auditing program as part of an overall GMP compliant Quality System. The auditing process plays a critical part in providing a safe and effective product from a practical business, regulatory compliance and most importantly the patient perspective.
Evaluation of suppliers and contractors is key to a successful Supplier/Vendor qualification process as well as in obtaining and maintaining regulatory approval. Though there are other aspects of the qualification process such as establishing a supply or manufacturing agreement, a quality or technical agreement and performing trial testing or manufacture, the performance of an audit allows for onsite real time assessment.
As the requirements and the process for Supplier/Vendor qualification must be detailed in a specific SOP there also must be a SOP that details the processes and procedures around external auditing. The SOP must describe the Why, When, How, Who, and the What of auditing. It should describe the auditing process from identifying contacts, setting a date, agreeing on an agenda, obtaining pre-audit information, supportive guides or checklists, and more. Importantly the SOP should also contain an element of risk analysis from the standpoint of what service is provided or where a component is used and any previous audit history. The different types of suppliers, vendors or contractors are described and the unique perspectives and preparation that must be taken into account for their audits. These include auditing of chemical RM or component suppliers; API, intermediate or Drug Product manufacturers; warehouses or distribution centers; and contract testing labs. In addition there are different types or styles of audits from a routine, to a for-cause or a mock pre-approval.
Behavior during an audit and the identification and communications of deficiencies or findings and closeout process will be discussed as well as the creation of the audit report and follow-up.
Why should you Attend:
The use of chemical and material suppliers, contract manufacturers and contract testing lab is integral in today’s pharmaceutical manufacture. With ever increasing diversity of WW suppliers and complexity in the regulatory and scientific realm of pharma manufacture the quality and control of materials and services in a cost effective manner is of paramount importance. The establishment of risk based a robust external auditing program is necessary as part of the qualification process of any vendor or contract organization.
The presentation will allow you to understand the why and how of developing and implementing such a program to allow control and confidence,
Areas Covered in the Session:
Who Will Benefit:
Joseph Habarta Ph.D. is founder and principal of J. Habarta Consulting that provides specialized consulting and assistance in the areas of international GMP and quality for the biotechnology and pharma industries. Dr. Habarta brings over 35 years of experience in these industries and has been a senior quality executive in both large pharma and start-up biotech organizations. His accomplishments range from numerous successful international PAI inspections to the establishment and advancement of cGMP quality organizations in many companies.
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Event Link : http://bit.ly/1OFoeuk