PHARMA/BIOTECH/MEDICAL DEVICES WITH MORF
Good Documentation Practices for FDA Regulated Companies from PHONIZE
Now on Mobile Devices
Good documentation processes are integral to a company’s overall quality management system (QMS). This comprehensive course provides clear guidance to managers and training personnel on how to formulate and deliver best documentation practices to their individual teams.
WHAT YOU WILL LEARN
This webinar will show you how to meet industry standards of documentation by demonstrating how best to record information as it relates to Good Manufacturing Practices (GMP), material or product identity, quality, purity, strength and safety, and consistent facility procedures. GDP are integral to a company’s overall quality management system (QMS).
BASIC & INTERMEDIATE
- The basics of Good Documentation Practices
- Explains the differences between documents vs records
- How to be compliant in writing or recording information via text, numbers, electronic signatures and more
- Compliance in amending documents or records
- Quality Control Personnel
- Supply Chain and Logistics Managers
- Regulatory Affairs Professionals
- Process Development Scientists and Management
- Manufacturing Management and Scientists
“This is a quote about the course and how amazing it is. How much it helps my business!”
Good Documentation Processes provide expert records, streamlines processes, reduces negative reviews and outcomes, and improves record consistency.
Provides a clear approach to correcting and preventing documentation issues, regulating consistent practices and avoiding negative reviews from the FDA and other agencies.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPs credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.
Course Author Bio
Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences
Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.