PHARMA/BIOTECH/MEDICAL DEVICES WITH XOOLI
Writing Effective SOPs for FDA and CLIA Regulated Companies from XOOLI
Now on Mobile Devices
Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 42. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or seemingly impossible. This often leads to regulatory errors that come to light during a FDA audit.
Every FDA and CLIA inspection starts with a review of SOPs. Thirty to forty percent (30%-40%) of adverse inspection issues are a result of poorly written SOPs.
WHAT YOU WILL LEARN
This course will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.
You will also gain a strategic view of how SOPs help streamline operations and create efficiencies, while ensuring regulatory compliance.
BASIC & INTERMEDIATE
- SOPs and their relation to the regulations
- SOPs as part of the company’s regulatory infrastructure
- Best Practices for writing SOPs to ensure conciseness, efficiency and ease of use
- Risk Based approach for writing SOPs
- Training on SOPs
- Tools for tracking SOPs life-cycle and when validation is required
- What an inspector looks for in SOPs during an inspection
- Regulatory VPs / Quality VPs / IT VPs
- Regulatory Affairs Professionals
- Quality Managers
- Quality Engineers
- Small Business Owners
- GxP Personnel
“Our quality managers enjoyed using XOOLI and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Well-written Standard Operating Procedures (SOPs) provide direction, improve communication, reduce training time, and improve work consistency.
SOPs used in combination with planned training and regular performance feedback lead to an effective and motivated workforce.
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.
XOOLI is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform
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.