2 Days Seminar FDA Trends in Compliance and Enforcement for Regulated Computer Systems

By: Carolyn Troiano, ERP Project Manager/FDA Compliance Consultant.
Product code: SEM51
Location 1: Richmond , Virginia Feb 28 - 01

Description

Course “Analytical Methods Validation and Transfer for FDA Compliance" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"


FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.
This session will provide some insight into current trends in compliance and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Areas Covered

•          Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
•          Understand “GxP” Systems
•          Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
•          Learn how Data Archival plays a key role in ensuring security, integrity and compliance
•          Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
•          Learn about recent FDA findings for companies in regulated industries
•          Learn about recent trends in technology that need to be addressed in the CSV approach
•          Q&A

Who will Benefit

Professionals in the following industries may also benefit from the content:
•          Pharmaceutical
•          Medical Device
•          Biotechnology
•          Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
•          Information technology managers and analysts
•          QC/QA managers and analysts
•          Clinical data managers and scientists
•          Compliance managers
•          Lab managers and staff
•          Automation analysts
•          Computer system validation specialists
•          GMP training specialists
•          Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
•          Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
•          Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc.)

Learning Objectives

Pharma , Medical Device & Biotech

Course Outline:

(8:30 AM – 4:30 PM)

Day One
Lecture 1: (90 Mins): 

•          FDA Regulatory Oversight 
•          Computer System Validation (CSV) 
•          System Development Life Cycle (SDLC) Methodology
Lecture 2: (90 Mins): 
•          GAMP 5 Software Categorization 
•          System Risk Assessment
Lecture 3: (90 Mins)
•          Requirements 
•          Design 
•          Testing 
•          Requirements Traceability Matrix (RTM) 
•          Additional Validation Documentation
Lecture 4: (90 Mins)
•          FDA Inspection Trends 
•          Regulatory Influences 
•          Response to Change

 

(08:30 AM to 04:30 PM)

Day Two
Lecture 1: (90 Mins): 
•          7 Most Common Problems with Validation
Lecture 2: (90 Mins): 
•          21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
Lecture 3: (90 Mins): 
•          FDA Audit Preparation
Lecture 4: (90 Mins):
•          Best Practices 
•          Wrap-Up
•          Q&A

 

speaker

Carolyn TroianoERP Project Manager/FDA Compliance Consultant

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

28-February-2019 To 01-March-2019 Richmond , Virginia
Seminar One Registration
$ 1596



Special Group Discount Register for Four attendees
$ 4796

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

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3 to 6 Attendees - 10% off

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10+ Attendees - 20% 0ff

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Venue to be announced shortly Richmond , Virginia

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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