e-Compliance Conference – 2020

ABOUT CONFERENCEFEATURED SPEAKERSCONFERENCE AGENDAPARTNERSSPONSORSHIPTESTIMONIALSFAQ'sT&C's
With ongoing digital transformation to ensures business continuity at all times, we bring you Global Experts at your fingertips. You’ll have opportunities to network with your fellow attendees and presenters, just like you would at our in-person events. Engage throughout the sessions, via the live chat, and during dedicated networking breaks and events.

During the conference, you can view presentations, access PDFs of the presentations, take downloadable notes in each session, participate in polls, chat with other attendees, and participate in LIVE Q&A sessions and Group Discussions with speakers.

At Compliance Trainings’ Virtual Conference, save time and ensure enhanced knowledge at ease.

Computer System Validation & IT Systems Validation Conference – 2020 (The First Ever CSV Virtual Conference) will provide you with suggestions on how the current regulatory developments have to be put into practice. Computer System Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for Computer System Validation, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include Computer System Validation.

This course will build on the Validation and 21 CFR 11 Compliance, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management.

The event is interactive and encourages the active participation of all attendees. Methodologies used in the lectures are workshops, keynotes and discussion sessions. We encourage delegates to use this opportunity to bring questions from your own practice up for discussions. The conference will have breakout sessions for delegates to choose their preferred track, consisting of workshops and keynotes divided for Technical (production & quality) & IT professionals.

REGISTRATION OPTIONS


* All prices mentioned are in USD


RECORDING ACCESS:   $ 4999  
Complete Conference Recording to Unlimited Viewers for 1 Month


1 DELEGATE (LIVE):     $ 799    


3 DELEGATES (LIVE):   $ 2199  


5 DELEGATES (LIVE):   $ 3199  


Download Brochure         Refund Policy

WHO SHOULD ATTEND

Industries

  • Pharmaceuticals
  • Medical Devices
  • Manufactures of APIs
  • Finished Products
  • Quality Control Laboratories
  • Contract Laboratories
  • Clinical Research Organizations
  • Biotechnology
  • Pharma Chemicals
  • Radiological Health
  • Regulated Food
  • Cosmetics
  • Pharma Software Developers
  • Automation & IT Companies

Departments

  • QA & QC
  • Regulatory Affairs
  • Research and Development
  • Training Departments
  • IT Departments
  • Documentation
  • Engineering
  • Manufacturing
  • Validation
  • Production
  • Laboratory Departments
  • Operations
  • Software Development
  • Facilities

Professionals

  • Directors, VP’s, CxO’s
  • General Managers
  • Senior Managers & Managers
  • Supervisors & Team Leaders
  • Validation Specialists
  • Documentation Specialists
  • Research Scientist
  • Project Managers
  • Analytical Chemists
  • Training Specialists
  • Auditors
  • Clinical Data Specialists
  • Technicians
  • Vendors & Suppliers

WHY CSV & IT VALIDATION
The FDA has issued many Warning Letters emphasizing Computer System Validation & Data Integrity non-compliance. These serious findings include:

  • Having interrupted
  • Missing, Deleted and Lost data
  • Inadequate records for risk analysis
  • Failure to exercise appropriate controls
  • Failure to validate computer software
  • Failure to establish validation procedures
  • Manipulation and deletion of audit trails.. and many more.

Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are on target of inspectors. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. To ensure that companies successfully pass Regulatory inspections and to also make sure that companies smoothly adopt latest tools & technologies available for validation, Compliance Trainings is pleased to announce the “CSV & IT Systems Validation Virtual Conference – 2020”.

TOP REASONS TO ATTEND
  • Connect with IT, CSV and validation experts within the life sciences industry
  • This CSV & IT conference is a proven venue for knowledge exchange and valuable hands-on learning
  • The conference features two main content streams to meet the educational requirements, mainly – Quality and IT
  • Stay Up-to-Speed with Regulatory Thinking
  • Shape and magnify your understanding of the regulatory requirements and expectations for the compliance of computerized systems used in pharmaceutical manufacturing
  • Learn to apply quality risk management and risk assessment concepts
  • Excellent networking opportunities to build relationships
  • Branding opportunities as well as taking advantage to meet potential clients face-to-face.

Our speakers come from all over the globe. You’ll hear from renowned industry leaders and visionary designers.



Orlando Lopez

E-Compliance & E-Records Quality SME


David Nettleton

CSV & FDA Compliance Specialist


Nichola Stevens

Current Chair of GAMP UK


Chinmoy Roy

DI, CSV & Process Automation SME


Carolyn Troiano

CSV Consultant


16 Amazing Keynotes

Learn and Network with the best in the Industry. The ultimate CSV & IT Validation experience!

Trev Simmons

Owner & Principal Consultant, TS CSV QA Ltd., UK

Heloisa Cytrynbaum

QMS & Data Integrity Expert, Brazil

Kalpesh Kumar Vaghela

CEO of Infra Control Systems

Ranjit Barshikar

QbD / cGMP Consultant

Suryamohan Surampudi

Head – Electronic Data Systems Compliance, Plant IT Systems & Automation, Dr Reddy’s Laboratories

Anand Rao. C

AVP, Head QA and CSV, Navitas Life Sciences

Aniruddha Mehta

Head QA-IT, Alembic Pharma

Venkat Srinivas

GM – Information Services, APAC Hub Lead, Apotex

Sudhir Kumar Gupta

Lead Quality , IT Department – Biopharma Division, Intas Pharmaceutical

…. More Speakers to be added shortly

DAY 1 - AUGUST 6, 2020 | 10 AM - 3 PM GMT
TIME (in GMT)AGENDA (DAY 1 - AUGUST 6, 2020)
10.00 AM - 10.15 AM
Introduction and Welcome Note
10.15 AM - 10.45 AM
Panel Discussion: Compliance Intelligence – Staying Up to Speed with Regulatory Requirements
10.45 AM - 11.30 AM
21 CFR Part 11, New Approaches to Old Tasks of Implementing Paperless Validation
11.30 AM - 11.45 AM
NETWORKING BREAK
BREAKOUT SESSIONSTRACK 1: Quality and Production FocusedTRACK 2: IT Focused
11.45 AM - 12.30 PM
Emerging Trends in Enforcement — A Review of 483s and Warning LettersEnsuring e-Records Integrity in the Cloud Environment
12.30 PM - 01.15 PM
Computer Validation Audits — The Good, The Bad and The UglyTo Audit or Not to Audit — Risk-Based Approaches for Cloud Vendor Management
END OF BREAKOUT SESSIONS
01.15 PM - 01.30 PM
NETWORKING BREAK
01.30 PM - 02.15 PMSDLC Modernization — Continuous Quality in an FDA-Regulated Environment and Journey to Paperless SDLC/CSV
02.15 PM - 03.00 PMPanel Discussion: Moving Towards Pharma 4.0 — Training and Testing of Machine Learning Models
DAY 2 - AUGUST 7, 2020 | 10 AM - 3 PM GMT
TIME (in GMT)AGENDA (DAY 2 - AUGUST 7, 2020)
10.00 AM - 10.45 AM
Group Discussion: Integrated Compliance — The Roles and Intersection of QA and IT
10.45 AM - 11.30 AM
GAMP® Methodology & The GAMP® 5 Approach
11.30 AM - 11.45 AM
NETWORKING BREAK
BREAKOUT SESSIONSTRACK 1: Quality and Production FocusedTRACK 2: IT Focused
11.45 AM - 12.30 PMBest Practices for Supplier Management and Vendor AuditingDeciphering IT Change Control
12.30 PM - 01.15 PMChange Control and Configuration ManagementCybersecurity and Compliance — The Future of Validation in GxP Systems
END OF BREAKOUT SESSIONS
01.15 PM - 01.30 PMNETWORKING BREAK
01.30 PM - 02.15 PMCSV — The Practical Path to Success
02.15 PM - 03.00 PMRisk-Based Validation of Software as a Service (SaaS)
DAY 3 - AUGUST 8, 2020 | 10 AM - 3 PM GMT
TIME (in GMT)AGENDA (DAY 2 - AUGUST 8, 2020)
BREAKOUT SESSIONSTRACK 1: Quality and Production FocusedTRACK 2: IT Focused
10.00 AM - 10.30 AM
Risk Assessment in Computer Systems ValidationImplement Process Mapping for IT Infrastructures
10.30 AM - 11.15 AMStrategic Approaches to Utilization of Automated Validation ToolsSoftware Testing Strategies for Computerized Systems Validation
END OF BREAKOUT SESSIONS
11.15 AM - 11.30 AMNETWORKING BREAK
11.30 AM - 12.15 PMGroup Discussion: Conducting Automation Validation – Strategies for MES, ERP and SAP Software Solutions
12.15 PM - 01.00 PMFree Slot for Sponsors
01.00 PM - 01.15 PMNETWORKING BREAK
01.15 PM - 02.00 PMData Integrity and Audit Trail Reviews
02.00 PM - 02.45 PMPanel Discussion: Moving from Computer System Validation to Computer Software Assurance. Is CSA the future? (covers latest FDA proposed guidance, AI, Augmented Reality, Machine Learning & BlockChain)
02.45 PM - 03.00 PMVote of Thanks and Close of Conference

EVENT PARTNERS, SPONSORS AND EXHIBITORS

MEDIA PARTNERS

    Sponsoring or exhibiting at Compliance Trainings’ eCompliance Conference 2020 is an excellent way to promote your business to a highly targeted group of key decision makers.
    This conference gives you the opportunity to present you latest offerings to existing clients, find new prospects, meet and network with Thought leaders & International Guru’s.

 

      POSITION YOUR COMPANY’S BRAND
    Showcasing your company at leading industry events establishes your company, in the eyes of your prospect or existing client.
      UNVEIL NEW PRODUCTS OR SERVICES
    Draw attention to your products and brand by using this conference as a launch pad for new products or services.
      BROKERING NEW BUSINESS PARTNERSHIPS
    Attendees are always looking for exciting new partnering opportunities. Our conferences offer you an ideal opportunity to make contact and capture future business leads.
      NEW MARKETS & GENERATE SALES LEADS
    Many Senior-level decision makers attend our conferences; connect with them in a collaborative environment by showcasing your services either by exhibiting or taking part in the conference.
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WHAT OUR PAST DELEGATES HAD TO SAY

 

1. What is a virtual conference?
A virtual conference is hosted entirely over the Internet. It will allow attendees to access live and hear presentations from their computers. Attendees participate through a conference website designed specifically for the virtual conference. Similar to a physical conference, there are keynote speakers, paper, panel and poster sessions, as well as sponsor booths. You will be able to ask questions and interact with speakers, sponsors and attendees in real time.

2. What are the technical requirements needed to participate?
To participate, you need an Internet connection and web browser. For the best viewing experience, we recommend Google Chrome. Internet Explorer is not recommended as some functions, may not be fully supported.

We’ll be streaming in HD but some computers and internet connections may not quickly auto-adjust to a lower resolution stream. If you experience buffering or issues with viewing the video stream, you may have a better viewing experience by reducing the quality to SD manually.

3. Do I need to download Zoom/Webex or other conferencing software?
No, you do not need to download any conferencing softwares as all attendees will join the virtual conference directly from the conference website. No installations will be required.

4. What happens once I register?
Once you register, you will receive an email with detailed instructions on how to connect to the conference.

5. Will I have access to the recordings and presentation materials?
All presentation materials will be available on the conference website for download. Please note some of the materials may not be available due to copyright issues. Some of the conference sessions will be recorded and posted on this site at the end of the event, so you can view any missed sessions at your convenience.

6. What if I can’t make the time to attend a particular session?
All sessions will be uploaded on the virtual conference website which you will be able to access up to 3 days after the conference. So it is better than a physical conference where you would have to choose between simultaneous sessions.

7. Who do I contact for technical help if I continue to have access problems after troubleshooting on my own?
Please contact info@webinarcompliance.com for technical assistance.

8. How do I register for the conference?
Our support team will be more than happy to answer all your delegate registration queires.
Please contact us by
Email: info@webinarcompliance.com
Phone: +1-416-915-4458

9. How do I pay?
Payment is required to be made at least 10 business days prior to the date of the conference. You can pay either by Credit or Debit Cards or Wire Transfer. Payments to be made in full, before the conference. Kindly feel free to contact our Customer Support to assist you with your registration. Customer Support: +1-416-915-4458 Email: info@webinarcompliance.com

10. What is substitution Policy?
If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

Terms & Conditions to Register for the Conference

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458
Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a $300 administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings / Webinar Compliance event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings / Webinar Compliance reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings / Webinar Compliance.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings / Webinar Compliance will issue a full refund.

Compliance Trainings / Webinar Compliance will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings / Webinar Compliance reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings / Webinar Compliance in writing as soon as possible.

Compliance Trainings / Webinar Compliance will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings / Webinar Compliance conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings / Webinar Compliance using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings / Webinar Compliance from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.