BEGIN:VCALENDAR
VERSION:2.0
PRODID:icalendar-ruby
CALSCALE:GREGORIAN
BEGIN:VEVENT
DTSTAMP:20240329T062650Z
UID:264478b3-de6b-4ad8-91eb-ccfa8b6a1586
DTSTART:20210420T130000
DTEND:20210421T130000
CLASS:PRIVATE
DESCRIPTION:
\nOverview
\nRegulatory bodies\; su
ch as\, the FDA and EMEA place a high level of scrutiny on a firm&rsquo\;s
validation program during GMP compliance inspections. Therefore\, it is e
ssential to an organization&rsquo\;s success to implement a robust\, compl
iant validation approach.
\nOne of the most critical factors in manuf
acturing pharmaceuticals and medical devices is ensuring that equipment us
ed for production is properly validated. \;Validation is required to d
emonstrate that equipment is fit for its intended use.
\nIn recent ye
ars\, there have been several standards and guidance documents created to
discuss best practices for commissioning\, qualification\, and validation.
One of these documents is the ASTM E2500 standard guide. Unfortunately\,
some of these documents are too vague and lack the details needed to provi
de adequate guidance and direction to the industry.
\nThis webinar di
scusses the concepts found in ASTM E2500 in sufficient detail to help indu
stry professionals understand how to implement a validation program based
on the ASTM 2500 \;Approach.
\nWhy an attendee will pay f
or this training? \;
\n
\nThis course provides deta
iled guidance on the concepts of ASTM 2500 and how to implement a validati
on program based on that approach.
\nWith limited guidance and experi
ence\, industry has been left to interpret how to adequately comply with t
he regulations. \;This course provides a comprehensive overview of the
regulatory authority requirements and expectations for a compliant valida
tion program and demonstrates how ASTM 2500 complies with those requiremen
ts.
\nBecause of the tremendous effort expended in conducting validat
ion studies\, efficiency and documentation will be stressed throughout the
discussion.
\nThis course will provide a thorough review of regulato
ry guidelines on validation. Each element required to have a complete and
thorough validation will be discussed in detail to ensure course attendees
have a clear understanding of each requirement.
\nSession Hi
ghlights
\n&bull\; Regulatory Requirements for a Com
pliant Validation Program
\no FDA
\no EU
\no ICH Q
7
\no ICH Q8: Pharmaceutical Development
\no ICH Q9: Quality Ris
k Management
\no Pharmaceutical cGMPs for the 21st Century: A Risk-Ba
sed Approach
\n&bull\; What is ASTM 2500
\no De
finition
\no Concept
\no Requirements
\no Differences from
traditional validation approach
\n&bull\; Real World Examples
of ASTM 2500 Implementation
\no Lessons Learned\n