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
FDA requires that all
computer systems that handle data regulated by the Agency 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 in the
1990s, as the first issuance addressed pharmaceuticals only. In 1997,
21 CFR Part 11 was issued to address electronic records and signatures,
as many 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, but still remains somewhat confusing. The intent
was to avoid creating a huge regulatory compliance cost to industry that
was initially preventing companies from embracing the technology.
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.
Who Will Benefit
- Information Technology Analysts
- Information Technology Managers
- QC/QA Managers
- QC/QA Analysts
- Clinical Data Managers
- Clinical Data Scientists
- Analytical Chemists
- Compliance Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Managers
- Manufacturing Supervisors
- Supply Chain Specialists
- Computer System Validation Specialists
- GMP Training Specialists
- Business
Stakeholders responsible for computer system validation planning,
execution, reporting, compliance, maintenance and audit
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
- Auditors engaged in internal inspection
Carolyn (McKillop) 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.
During her
career, Carolyn worked directly, or on a consulting basis, for many of
the larger pharmaceutical companies in the US and Europe. She developed
validation programs and strategies back in the mid-1980s, when the first
FDA guidebook was published on the subject, and collaborated with FDA
and other industry representatives on 21 CFR Part 11, the FDA’s
electronic record/electronic signature regulation.
Session 1 (90 Mins):- FDA Regulatory Oversight
- Computer System Validation (CSV)
- System Development Life Cycle (SDLC) Methodology
- GAMP 5 Software Categorization
- System Risk Assessment
Session 2 (90 Mins):- 21 CFR Part 11 Compliance (Electronic Records/Electronic Signatures)
- Security, Access, Change Control and Audit Trail
- Validation Documentation
Session 3 (90 Mins):- 7 Most Common Problems with Validation
- FDA Audit Preparation
Session 4 (90 Mins):- Policies and Procedures
- Training and Organizational Change Management
- Industry Best Practices and Common Pitfalls
- Q&A
