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Live Webinar 90 minutes Biopharmaceutical Analytics: Regulations
Date
Jun 10, 2021 - 01:00 PM
- Jun 11, 01:00 PM
Link to Website
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,
Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671
Overview
The primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced: Biopharmaceuticals are manufactured in living organisms such as bacteria, yeast and mammalian cells, whereas traditional pharmaceuticals are manufactured through a series of chemical synthesis.
Biopharmaceutical products make up an increasing share of new approvals from the US Food and Drug Administration. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. It’s by far the fastest-growing part of the industry.
Quality functions are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. The industry has received an unprecedented number of warning letters and remediation programs in the last five years, and scrutiny is unlikely to decrease. Furthermore, the increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes.
Why should you attend
Biopharmaceutical companies best positioned to succeed in tomorrow’s market will be those that master a broad set of technical and operational capabilities; as well as, ensure adherence to cGMP compliance requirements.
Attendees of this course will gain a clear understanding of the regulatory requirements governing biopharmaceuticals.
This course will also provide a detailed discussion on the topic of validation.
Who will benefit
The primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced: Biopharmaceuticals are manufactured in living organisms such as bacteria, yeast and mammalian cells, whereas traditional pharmaceuticals are manufactured through a series of chemical synthesis.
Biopharmaceutical products make up an increasing share of new approvals from the US Food and Drug Administration. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. It’s by far the fastest-growing part of the industry.
Quality functions are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. The industry has received an unprecedented number of warning letters and remediation programs in the last five years, and scrutiny is unlikely to decrease. Furthermore, the increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes.
Why should you attend
Biopharmaceutical companies best positioned to succeed in tomorrow’s market will be those that master a broad set of technical and operational capabilities; as well as, ensure adherence to cGMP compliance requirements.
Attendees of this course will gain a clear understanding of the regulatory requirements governing biopharmaceuticals.
This course will also provide a detailed discussion on the topic of validation.
Who will benefit
- Production
- QC Micro
- Engineering & Validation
- Facilities / Maintenance
- Quality Assurance
Speaker Details
Speaker
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.
Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671
Don't wait. Register TODAY or Email US [email protected]
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.
Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671
Don't wait. Register TODAY or Email US [email protected]