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How many times have you heard: if it isn’t written down, it didn’t happen? Documents and documentation are the foundation of the pharmaceutical arena. Procedures must reflect practices and practices must reflect procedures. Proper preparation, completion and management of clear and concise documents result in productive and compliant operations, fewer deviations, and a positive impact on the bottom line. During this course, the instructor will examine FDA and EU regulatory requirements and expectations for GMP/GDP documents, how to prepare those documents, and the completion and management of documentation, as well as the consequences of non-compliance.

Documents such as Standard Operating Procedures (SOPs), Work Instructions (WIs), forms and batch records are a fundamental part of a successful quality system. These documents establish, secure, control and monitor tasks, and serve as evidence of compliance. Poorly written documents are of limited value; the best-written documents are worthless if they are not followed. To that end, companies must prepare and write effective procedures with consistency, clarity and credibility.

Documentation is an everyday activity. Whether to demonstrate production activities, describe investigations or finalize product release, the recording of sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, employees must follow good documentation practices and properly manage documents.

In this course, identify why some documents are difficult to use and not readily accepted by the users and then reveal methods for the preparation, development and storage of documents. Also, learn to examine and diffuse the difficulties in using and managing documents by understanding key aspects of good documentation practices and those illusive and erroneous documentation management systems and activities that linger in our facilities.

Who Should Attend

This course is for individuals who are responsible for creating and/or authoring documents and ensuring readiness for the application and use in a GMP/GDP (Good Distribution Practices) environment. Individuals who conduct internal GMP/GDP audits will also benefit from this course.