Using Excel Spreadsheets in FDA Regulated Environment

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Using Excel Spreadsheets in FDA Regulated
Environment

• Who can attend
• System owners and personnel who create or use
  spreadsheets in FDA regulated areas
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Regulatory affairs and training personnel

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
2
Webinar Description
Excel spreadsheets are easy and convenient to use
for handling common data capture and analysis
functions. FDA accepts data in Excel spreadsheets
provided it meets the criteria of confidentiality
and integrity defined within 21 CFR Part 11, GAMP
5 and related regulations. Excel can be made FDA
compliant with simple procedures and practices to
meet regulatory requirements. This seminar
provide insight into regulatory requirements and
inherent limitations in Out of the Box Excel,
validation techniques, documentation
requirements, and risk-based evaluation of Excel
spreadsheets. Practical strategies and case
studies will be used to highlight common issues
and potential solutions.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
3
Why Should you Attend
Capability to use Excel creates an inexpensive
and handy tool for FDA regulated industry,
particularly RD operations and early stage
development activities. However, companies
frequently struggle with understanding and
implementing applicable regulations on
spreadsheets. Many companies use invalidated
spreadsheets leading to negative audit findings.
This seminar will address all these issues by
providing methods for planning and executing
spreadsheet validations that satisfy FDA
requirements.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
4
Objectives of the Webinar

• Regulatory requirements for spreadsheets
• Spreadsheet design considerations and validation
  methods
• Risk based evaluation and qualification of
  spreadsheets
• Documentation requirements
• Common FDA audit findings and solutions

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
5
Instructor Profile
Mukesh Kumar Senior Director Regulatory Affairs
and Quality Assurance
Mukesh Kumar, leads the Regulatory Affairs and
Quality Assurance departments at Amarex Clinical
Research, a full service CRO based in Germantown,
MD. His key expertise is in developing Global
Regulatory Business Strategies for biomedical
product development and his passion is to bring
traditional therapies for India, China and the
Latin-America to the Western markets. In addition
to regulatory expertise, Mukesh is an experienced
auditor and a trainer in regulatory and business
processes.Mukesh started his professional
career as a research scientist at the NIH, Baylor
College of Medicine, Houston, and several premier
institutions in India. With more than 11 years of
experience in virology, gene therapy, and
molecular biology, Mukesh has expertise in
biological and combination products. He has been
a global Regulatory Affairs Specialist (US, EU,
and India) for the last 5 years. He has filed
several new-INDs for drugs, biologics and
combinations products, NDAs, 510K, PMAs, etc. He
has made several hundred FDA submissions, and
arranged a number of meetings and responses to
FDA comments. In addition, he has had made
regulatory submission in the EU and India. Mukesh
has reviewed/compiled more than 100 clinical
trial protocols and has supervised more than 60
multi-national clinical trials (both under IND
and non-IND trials), in the US, Canada, Latin
America, Africa, and Asia. In addition to drugs
and Biologics, he has extensive experience in
medical device and diagnostic product regulatory
filings and safety monitoring.Specialties
Technology transfer, global regulatory strategy,
global clinical trials, safety reporting,
training, and GLP/GCP audits.Honors and Awards
US patent awarded "Gene Therapy vectors derived
from Sendai virus".Education Education Delhi
University - Ph.D., Biochemistry - 1993 1997
National Dairy Research Institute - MS,
Biochemistry - 1990 1993
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
6
About OnlineCompliancePanel
Online Compliance Panel creates and delivers
comprehensive industry relevant training
sessions. These sessions are simple, interactive
and cost effective. We are a predominantly web
based information exchange forum. Live
interactions on compliance training make the
process holistic and effective. Online Compliance
Panel largely emphasizes in offering regulatory
compliance training to compliance professionals
on varied topics. These primarily include risk
management, quality management, corporate
compliance and other regulatory compliances. Some
of our primary areas of focus include advancement
and updates in regulatory compliance, best
practices and market trends.We strive to
incorporate high standards in developing a
culture facilitating exchange of ideas resulting
in functional excellence. Online Compliance Panel
believes in nurturing ideas and thought processes
through innovative e-learning methodologies. Our
products and services are designed to offer
customized solutions to industry and market. We
bridge the gap between experience and knowledge
thus delivering original and creative
content.Our objectives of employing interactive
mediums ensure effective communication and mutual
exchange of ideas. Online Compliance Panel
closely follows best practices and regulatory
trends in the global compliance scenario. We also
observe and communicate trends witnessed in FDA,
ISO regulations, process and design validation.
All updates and additions to important laws can
be accessed by our customers in real time.Our
mission is to empower compliance professionals
through effective online training sessions. Our
world class training methodologies stem from
comprehensive understanding of client
requirements. The content conforming to FDA and
ISO standards is developed by well qualified and
experienced industry leaders. Our offerings will
exceed expectations and add value to your
investment.The content in various categories
such as medical devices, pharmaceuticals and
biotechnology will raise the bar in terms of
quality already on offer .We hope to contribute
to the creation of responsible organizations
creating benchmarks in quality, integrity and
transparency.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
7
Using Excel Spreadsheets in FDA Regulated
Environment
Register Here http//bit.ly/UsingExcel_FDA
For more details please contact
customersupport_at_onlinecompliancepanel.com
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com