PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
Writing Effective SOPs for FDA and CLIA Regulated Companies from PHONIZE
Now on Mobile Devices
PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
Writing Effective SOPs for FDA and CLIA Regulated Companies from PHONIZE
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.
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- 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
PERFECT FOR
- CEOs
- Regulatory VPs / Quality VPs / IT VPs
- Regulatory Affairs Professionals
- Quality Managers
- Quality Engineers
- Small Business Owners
- GxP Personnel
- Consultants
“Our quality managers enjoyed using PHONIZE 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.