Webinar on Good Documentation Practices for GxP Compliance

Website http://bit.ly/1Kf003R | Edit Freely

Category Good Documentation Practices; GxP Compliance; Online Compliance training

Deadline: October 13, 2015 | Date: October 14, 2015

Venue/Country: Fremont, U.S.A

Updated: 2015-09-22 14:36:51 (GMT+9)

Call For Papers - CFP

Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

Why should you Attend:

Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, all employees must follow good documentation practices.

The use of GDP allows companies to comply with regulatory requirements such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) or the applicable quality management system (for example, ISO 13485, 21 CFR parts 11,211,312,and 820), or Good Clinical Practices (GCP).Documentation that is used in support of manufacturing, laboratory and clinical practices should adhere to GDP.

According to the FDA, if it isn't written down, it didn't happen. As well, if it isn’t written down clearly, it didn’t happen either. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance.

Areas Covered in the Session:

Document System

What is Documentation?

Type of Documents

Good Documentation Practices

Good Documentation requirements

Documentation Processing and Control

Guidance documents for GDP

Who Will Benefit:

Anyone who authors, reviews, and audits documents and records in FDA-regulated pharmaceutical, biotechnology, and medical device industries

Clinical research associates

Manufacturing/Production personnel

Laboratory personnel

Research and Development associates

Document Control associates

Batch record reviewers

QA/QC specialists

Validation engineers

Quality Assurance auditors

Regulatory Compliance Associates and Managers

Speaker Profile:

Alla Teresh ASQ CQA, has over 11 years of comprehensive experience in documentation audit and management within the medical device industry. During her practice, she designed and implemented a document control system for a startup company that was audited for and awarded an FDA medical PMA and 510K, CE Mark Approval for distribution in Europe. Her skills include a high level of proficiency in conducting technical reviews and managing quality system documentation.

Contact Detail:

NetZealous - Compliance4All,

161 Mission Falls Lane, Suite 216,

Fremont, CA 94539, USA.

Phone: +1-800-447-9407

Email: supportcompliance4All.com

http://www.compliance4all.com/

Event Link : http://bit.ly/1Kf003R