Computer Systems Validation (CSV) – Avoiding The Top Five Regulatory Pitfalls
Computer Systems Validation (CSV) warning letters and overall enforcement action has increased significantly over the last five years. Particular focus on CSV has occurred, in part, due to the growing number of clinical trails and increase in data generation streams. Enforcement actions have resulted in longer regulatory approval times, increased generic competition, and growing costs for overall product development.
This course will focus on the current top five FDA regulatory trends, warning letters and enforcement actions related to Computer Systems Validation (CSV), where you will learn the following:
- Why you’ll be cited: deficiencies with data capture, storage and validation
- How to develop SOPs that will mitigate risks and avoid costly setbacks
- Prepare for, survive, and thrive under any audit or enforcement action
Additionally, the learning objectives of this course will focus on preventing CSV outcomes that will have a negative impact on patient safety and your profitability. During this interactive 90-minute session, you will learn:
- Top examples of Consent Decrees focusing on CSV
- Interpretation of past, present and future changes to FDA Guidance’s surrounding CSV
- Financial and compliance impact to FDA’s current enforcement trends
- Current CSV industry techniques and philosophies being deployed in the pharmaceutical marketplace for product quality and audit success
- Utilization of automated CSV tools to ease overall validation programs
This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.
Michael Crowthers serves as Senior VP, Professional Services for QPharma, Inc., a consultancy serving the regulatory and brand support needs of the pharmaceutical, medical device and other life science industries. In his role with QPharma, Mr. Crowthers oversees the firm's regulatory compliance and quality consulting operations worldwide. He possesses extensive experience in strategic project management, computer systems validation, and regulatory compliance consulting.
Mr. Crowthers is a Life Sciences professional with extensive experience in IT process compliance and computer systems validation (CSV) and verification activities in various sectors of business in the Life Sciences industry. His thought leadership around cost-effective and process efficient IT compliance has served organizations varying in size and complexity to apply a practical and maintainable approach to systems implementation as well as compliance and validation.
Mr. Crowthers has been an active speaker and trainer at various Life Sciences conferences, most notably the Institute of Validation Technology (IVT). His conference forums have focused on the areas most crucial to successful validation including Risk Management and Configuration/Change Management. Mr. Crowthers is also an active member of the International Society for Pharmaceutical Engineering (ISPE) and is well versed in the principles of GAMP5®.