The Hitchhiker's Guide to 483s and Warning Letters

Description:

Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.

Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar, will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.

Objectives of the Presentation:

• FDA Inspections - background
• Causes of Form 483 / Warning Letter
• Some recent results of companies failing to respond appropriately
• Best Practices for Responding to 483
• Best Practices for Responding to Warning Letter
• What to do if the responses fail

Who can Benefit:

• CEO
• Regulatory VP
• Quality VPs
• IT VPs
• Regulatory Affairs Professionals
• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP
• Consultants

Live Session - How it works

• We will send Username and password 24 hours prior to webinar at your email address.
• Webinar presentation handouts will be shared in pdf format, a day before live presentation.
• Use the login details to participate in sessions.
• Clear out your queries through interactive Q&A chat boxes with the speaker.
• We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
• Get certification of attendance.

Recorded Session - How it works

• Once you purchase a webinar you will receive username and password at your email address.
• Use the login details to view recorded webinars.
• Presentation handouts will also be shared in pdf format.
• Access to the recording is valid only till 6 months starting from the date of purchase.
• Get certification of attendance.

Project Management for Computer Systems Validation

Description:

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.

Agenda

• Project Management Basics
• 21 CFR 11 and Computer Systems Validation (CSV)
• The Project Charter
• CSV Deliverables
• Hiddent CSV Deliverables
• Metrics & Gantt Charts
• The 10 Deadly Sins!!
• Q&A

Why Should you Attend:
Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance.

The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market. This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Objectives of the Presentation:

• Basics of Project Management
• Basics of Computer Systems Validation
• Project Planning for a Computer Systems Validation Project
• Common Pitfalls and How to Avoid them

Who can Benefit:

• Project Managers
• IT Management
• Business Process Owners
• Quality Managers
• Quality Engineers
• GxP
• Consultants

Live Session - How it works

• We will send Username and password 24 hours prior to webinar at your email address.
• Webinar presentation handouts will be shared in pdf format, a day before live presentation.
• Use the login details to participate in sessions.
• Clear out your queries through interactive Q&A chat boxes with the speaker.
• We need to know your experience, so please don't skip to provide us with your overall presentation feedback.
• Get certification of attendance.

Recorded Session - How it works

• Once you purchase a webinar you will receive username and password at your email address.
• Use the login details to view recorded webinars.
• Presentation handouts will also be shared in pdf format.
• Access to the recording is valid only till 6 months starting from the date of purchase.
• Get certification of attendance.