2014 - Preparing for an FDA API GMP Inspection

Instructor: Max Lazar
Description:
Over the past 2 years, FDA inspections of API sites have uncovered significant violations and resulted in major regulatory action. FDA Inspectors continue to observe an increasing level of deficiencies at these facilities. This trend is troubling and createsoperating and business problems for both the API industry and the consumers of their products - Drug Product manufacturers. Even more important is the potential risk to human and animal health that may exist due to these GMP violations!
This program will examine what is necessary to prepare and minimize critical deficiencies at an inspection site. It will examine key areas and issues for consideration by both producers of API and the firms that buy from API manufacturers.
What does the buyer of an API and the manufacturer of the ingredient need to consider and examine from both a short term and long term perspective? Knowing what priorities to set are important for success. The program can also be beneficial to manufacturers of excipients since similar principles that exist in the API GMP are applicable to excipient manufacturing. What is presented in this Webinar will prove useful to the program participants that are concerned with passing inspections conducted by FDA and similar regulatory agencies from other countries. All these elements will be examined during this program. An opportunity will be provided to discuss areas of concern with the expert instructor.
Participants should have a background or actual experience with producing, testing, auditing, or other relationship with API sites. The program also has application to excipient users and manufacturers.
Why Should you Attend:
Recent regulatory experience provides a strong need for both producers and consumers of API to improve the API GMP application at manufacturing and control sites. You will get insight into what and why API sites are performing poorly during inspections and insights into what you need to do.
Objectives of the Presentation:
What are the causes of GMP violations
Why do they exist
Identifying critical reviews to perform
What are the most important short term actions?
What are long term activities that help prepare the organization to succeed?
Who can Benefit:
API and Excipient producers and consumers (Drug Product Firms)
Supervisory personnel responsible for any API functions
Quality Management
Materials Management - purchasing, warehousing and distribution
R&D personnel associated with API methods, validations, cleaning procedures, scale ups and specifications
Laboratory Supervision
Manufacturing chemists, Engineers
Functions that have an interest in becoming familiar with API GMP and its business impact.
Quick Contact
http://www.onlinecompliancepanel.com/ecommerce/web...
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Toll free: +1-510-857-5896
Email:?webinar-AT-onlinecompliancepanel.com
OnlineCompliancePanel LLC,
38868 Salmon Ter,
Fremont, CA 94536, USA