21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

Start Date : September 6, 2018
End Date : September 7, 2018
Time : 9:00 am to6:00 pm

Phone : (800) 447-9407
Email : globalcompliancepanel@gmail.com

Location :
Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA

Website

Description


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.

Description:

The seminar 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:


Who Will Benefit:

You should attend this seminar 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 seminar include:

This seminar 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 (90 Mins):

“GxP” Computer Systems and FDA Oversight


Lecture 2 (90 Mins):

Computer System Validation (CSV)


Lecture 3 (90 Mins):

System Development Life Cycle Management (SDLC) Methodology


Lecture 4 (90 Mins):

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

Day 2 Schedule


Lecture 1 (90 Mins):

Strategic Approach to ER/ES Compliance


Lecture 2 (90 Mins):

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


Lecture 3 (90 Mins):

Training and Organizational Change Management Best Practices


Lecture 4 (90 Mins):

Industry Best Practices and Common Pitfalls

Speaker:

Carolyn Troiano

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 Richmond, VA area.

 

Location:  Seattle, WA Date: September 6th & 7th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA

 

Price:

Price: $1,495.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*

Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*

Sponsorship Program benefits for seminar

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link – https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901789SEMINAR?seo

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Registration Info


Cost :

Event link :
  https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901789SEMINAR?meetings4docs-sep-seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

Tel: 800-447-9407
Email: globalcompliancepanel@gmail.com
Website: https://www.globalcompliancepanel.com/


Event Categories: Health & Nutrition.

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