FDA-Compliant Strategic Software Validation Planning for Senior Management | Oct. 23, 2013, 2 PM EDT | Fuller
August 23rd, 2013 // 1:27 pm @ jmpickett
This new Webinar on FDA software validation training will detail how you as a senior manager should approach software validation so you will be able to easily satisfy new FDA compliance initiatives.
In recent years, FDA has put in place many new enforcement initiatives that affect software validation, and will also affect your regulatory risk level. How well prepared are you for software quality, software validation, and compliance with 21 CFR Part 11?
Automated manufacturing, as well as complex systems in the laboratory, QC, CA, complaints, CAPA and AERs put companies at a higher risk for serious enforcement action. FDA staff in the field is now well trained on software validation, as well as 21 CFR part 11 inspections. Many drug and device companies are behind the times in their software validation.
With this Webinar, you can move forward with your planning in this vital area. This planning session for senior managers will discuss the key areas of software validation on which to focus. After attending, you will know just how FDA approaches software validation enforcement today, and how to prevent unnecessary FDA audits. You also will know how you can satisfy the inspector during an audit of your software validation systems.
Areas Covered
- Outline of new software validation enforcement efforts by FDA.
- When and why FDA will issue a warning letter for software validation problems.
- What happens after a Warning Letter is issued under the new enforcement system?
- How planning can help now and in the future.
- The pivotal role of the Director of Software Quality / Software Validation.
- How your people can really help or hurt you.
- Effective software quality / validation structure.
Who Should Attend
This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics, Biological manufacturers, and outside support staff. The staff members who will benefit include:
- VP-Quality
- Director-Software Quality
- Director-Quality
- Director-Validation
- Manager-Software Quality
- Manager-Validation
- IT/IS Managers
- Regulatory Affairs
- Legal / General Counsel
- CIO/CFO
- Legal Staff/Attorneys
- Audit/Inspection coordinators
- internal auditors
- QA / QC managers, executives and personnel
- IT / IS managers and personnel
- Validation specialists
- Software quality reviewers
- Consultants
What Is Included
With your order, we would like to offer you these six items at no added cost:
- Powerpoint slides to share
- Downloadable recording
- Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
- Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
- Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
- Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00
About the Speaker
Alfonso Fuller is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.
