Good Documentation Practice (GDP) - Online Live Training (Hebrew)

Good documentation practice (GDP) is a set of guidelines for creating and maintaining documents in industries. These guidelines ensure that documents are accurate, complete, and legible, and that they can be traced back to the original source.

GDP is important for several reasons: it helps to ensure the quality of products and services; it provides a record of activities that can be used to track and investigate problems and it helps to comply with regulatory requirements.

Training Content:

• The importance of GDP
• The principles of GDP
• The different types of documents that fall under GDP
• The requirements for document preparation, review, approval, issuance, storage, and archiving
• The consequences of non-compliance with GDP
• Poor GDP examples

The training includes examples from the industry of how companies have implemented successful good documentation practices.

Intended for: Employees and managers of medical device companies: Quality, Design, Manufacturing Associates, Engineers and Managers.

About the trainer:

Helit Dovrin - Executive Consultant, Coach, Auditor and Lecturer worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson.

Helit gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.