21 CFR Part 11 Validation Checklist | Computer Systems Validation

21 CFR Part 11 Validation Checklist | Computer Systems Validation

 

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About The Event

 

Course "21 CFR Part 11 Compliance for Computer Systems Regulated by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

 

 

 

Overview:

 

 

 

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

 

FDA's 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system. Rule for changing passwords must be rigorously adhered to and the passwords must be kept secure.

 

It is also critical that the system specify the exact meaning of the signature. It may be that the person conducted the work, recorded the result, reviewed the result, or approved the result. A person may simply be attesting to the fact that they reviewed the work and the signatures, and there was appropriate segregation of duties (i.e., the person recording the result is not the same as either the person reviewing or the person giving final approval).

 

A company must have specific policies and procedures in place that explicitly state responsibilities and provide guidance for implementing and using ER/ES capability. These must clarify the 21 CFR Part 11 regulation and provide insight as to the way the company interprets their responsibility for meeting it. As FDA continues to evolve and change due to the many factors that influence the regulatory environment, companies must be able to adapt. New technologies will continue to emerge that will change the way companies do business. While many of these are intended to streamline operations, reducing time and resources, some unintentionally result in added layers of oversight that encumber a computer system validation program and require more time and resources, making the technology unattractive from a cost-benefit perspective.

 

 

 

Why you should attend:

 

 

 

This seminar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

 

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

 

 

 

Areas Covered in the Session:

 

 

 

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy
  • System Risk Assessment
  • GAMP 5 "V" Model
  • 21 CFR Part 11
  • Electronic Records/Electronic Signatures (ER/ES)
  • Security, Access, Change Control and Audit Trail
  • Policies and Procedures
  • Training and Organizational Change Management
  • Industry Best Practices and Common Pitfalls

 

 

 

Who will benefit:

 

 

 

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

 

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing and Supply Chain Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
  • Business System/Application Testers in FDA-Regulated Functional Areas

 

This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

 

 

 

Agenda:

 

 

 

Day 1 Schedule

 

 

 

Lecture 1:

 

"GxP" Computer Systems and FDA Oversight

 

Lecture 2:

 

Computer System Validation (CSV)

 

Lecture 3:

 

System Development Life Cycle Management (SDLC) Methodology

 

Lecture 4:

 

FDA's 21 CFR Part 11 (Electronic Records/Electronic Signatures) Guidance

 

 

 

Day 2 Schedule

 

 

 

Lecture 1:

 

Strategic Approach to ER/ES Compliance

 

Lecture 2:

 

Policies and Procedures to Support GxP Compliance with 21 CFR Part 11

 

Lecture 3:

 

Training and Organizational Change Management Best Practices

 

Lecture 4:

 

Industry Best Practices and Common Pitfalls 

 

 

 

 

 

Speaker

 

Carolyn Troiano

 

IT Program Manager and FDA Compliance Consultant, Smart Resources, Inc. 

 

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

 

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Los Angeles, CA area.

 

 

 

 

 

 

 

 

 

 Location: Boston, MA Date:  January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM

 

Venue: Embassy Suites Boston Logan Airport   207 Porter St, Boston, MA 02128, USA

 

 

 

Price:

 

 

 

Price: $1,295.00 (Seminar Fee for One Delegate)

 

Register now and save $200. (Early Bird)

 

Until December 10, Early Bird Price: $1,295.00 From December 11 to January 23, Regular Price: $1,495.00

 

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 

Register for 10 attendees   Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

 

 

 

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

 

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

 

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

 

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

 

 

 

Contact us today!

 

 

 

NetZealous LLC DBA GlobalCompliancePanel

 

john.robinson@globalcompliancepanel.com  

 

support@globalcompliancepanel.com 

 

Toll free: +1-800-447-9407

 

Phone: +1-510-584-9661

 

Website: http://www.globalcompliancepanel.com

 

 

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901300SEMINAR?meraevents-January-2018-SEO

 

 

 

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