BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T232836Z UID:0f3c5fb2-7e94-42e0-b04b-c31d3da2a212 DTSTART:20210309T130000 DTEND:20210310T130000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nAnnual Product Quality R eview (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize the product defec ts and also the risks associated with the manufacturing of the pharmaceuti cal product.
\n\nThis webinar will give a brief overview of the gene ral procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requ irements as per US and Europe. It will also discuss the comparative evalua tion about similarities and differences of requirements associated with th e manufacturing of the drug product in different countries. It is also nec essary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharma ceutical product.
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\n\nSession High lights
\n\nThis webinar will review:
\n&bull\; Annual
Product Review definition
\n&bull\; What needs to be included in the
report
\n&bull\; A model of an example Annual Product Review Report\n&bull\; Review of citations
 \;
\n\n&bull\; Disc
uss how to write APRs
\n&bull\; Outline the requirements for APR repo
rting
\n&bull\; Review what information to include in the reports
\n&bull\; Discuss how well written APRs benefit your firm&rsquo\;s compl
iance
 \;
\n\nWho will Benefit
\n\n&bull\; QA staff and management
\n&bull\; Compliance Pers
onnel
\n&bull\; Regulatory Affairs staff and managemen