Building a Vendor Qualification Program for FDA Regulated Industries

"Building a Vendor Qualification Program for FDA Regulated Industries" Seminar has been added to ComplianceOnline.com's offering.

SAN JOSE, CA, UNITED STATES, November 11, 2021 /EINPresswire.com/ -- ComplianceOnline, the leading provider of regulatory compliance training, announced a new educational seminar for FDA-regulated companies on the topic ‘Building a Vendor Qualification Program.’ The November 17-18, 2021 seminar is led by subject matter expert Joy McElroy offering attendees a practical approach to understanding the procedures for a “robust supplier quality audit program’’ says the event overview.

Supply Chain Personnel, Quality Assurance and Quality Controls Managers, Supervisors and Directors, Research & Development Directors, and Senior Analysts in Chemistry and Microbiology should explore this seminar to gain a better understanding of what is required by law:

• 21 CFR Part 211.84, Testing and approval or rejection of components, drug product containers, and closures
• FDA’s Drug Supply Chain Security Act (DSCSA)
• Current Good Manufacturing Practice for Finished Pharmaceuticals and
• ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients)

Attendees will also learn about estimating the time and travel expenses for supplier quality audits and how to write audit agendas. The recommended contents of a Supplier Quality Audit Report will also be taught during this presentation.

The seminar will cover the following areas:

• The qualifications of a supplier quality audit
• The contents of an adequate supplier quality audit
• Scheduling and planning audits
• The required length of audits
• Ensuring that all questions are adequately conveyed and understood by our suppliers
• How to convince the suppliers that our audits must be accepted and scheduled
• What do we do if the suppliers require us to pay a fee to audit them?
• Do we need secondary suppliers for every component we use?
• Learning how to deal with the difficulties of obtaining Travel Visas
• How to maintain good conduct and respect during audits
• Follow-up on previous audit observations
• The importance of learning the frequency and results of previous Regulatory Audits

For more information or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: November 17-18, 2021 (10:00 AM - 5:00 PM EST)

About the Speaker:

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With over 20 years of total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

About ComplianceOnline.com:

ComplianceOnline is a leading provider of regulatory compliance training programs for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC), and Quality Management Solutions for global corporations.

For more information on ComplianceOnline or to browse through our training programs, please visit our website.

Priyabrata Sahoo
ComplianceOnline
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