RSS Events Feeds

Good Documentation Practices for Laboratory Operations Webinar by GlobalCompliancePanel

9/24/2013 10:00 AM - 11:00 AM

Overview: 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, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. 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. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. 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. During this webinar, you will review agency and industry standard expectations of Good Documentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical laboratory.

Why Should You Attend:

Discover what the FDA and EU regulations say about documentation

Learn what your signature and/or initials mean on a document

See how to handle and manage data entry and errors

Review "Do's" and "Don'ts" of documentation practices

Discuss rounding and limit expression determinations

Recognize how to sign, date and label data and records

Identify non-compliant documentation practices

Demonstrate how to attach raw data to forms and lab notebooks

Explore what FDA investigators actually look for during a lab inspection

Areas Covered in the Session:

21CFR and Eudralex references to documentation

Correcting errors and omissions

Dates and formats

Meanings of initials and signatures

Use of "NA"

Comments and explanations

Handling raw data (charts, strips, printouts)

Blanks

Entering numerical data

OOS Documentation Expectations

FDA Investigator strategies

Who Will Benefit:

Chemists and Analysts

Laboratory Technicians

Laboratory Supervisors

Laboratory Managers

QA Auditors of Laboratory Documents

Metrology personnel

Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/14mLdzr

Learn More: Good Documentation Practices for Laboratory Operations Webinar by GlobalCompliancePanel

Events Map

Email Newsletters

Want to be up-to-date with the latest news and updates from Entrepreneurship.org? To subscribe, just give us your email address below; you'll choose which e-newsletters you'd like to receive on the next screen.