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Regulations and Good Manufacturing Practices in Biotechnologies

$247.50

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Students can receive an additional 20% discount by uploading a student ID during checkout. No discount code required.

BTBS866: Regulations and Good Manufacturing Practices in Biotechnologies. This certification provides a comprehensive review of the role of regulation in biopharmaceutical technology products and services development and commercialization. The certification covers in general the current regulations that applied to Puerto Rico and USA including overview of OSHA, PROSHA and EPA/EQB with major focus on FDA rules and regulations. Certification emphasis will be in and Good Manufacturing Practices (cGMP’s), quality awareness, record integrity, documentation, 483’s, business impact in dollars and jobs. Safety, recall cases, liabilities and basic in auditing.

SKU: BTBS866 Category:

Course Information

  • Positioning: Regulations and GMP for quality, compliance, documentation, and regulated manufacturing.
  • Audience: quality, manufacturing, documentation, validation, compliance, laboratory, and supervisory personnel.
  • Key learning: cGMP, FDA concepts, OSHA, PROSHA, EPA/EQB, documentation, record integrity, 483s, safety, and audits.
  • Format: approximately 25 to 45 hours of training, depending on the course scope and learner pace; online and self-paced.
  • Languages: Available in English, Spanish, or Portuguese, depending on availability.
  • Short tests: Included to verify understanding and progress.
  • Certificate: Issued by IBI/BiotechCenters after final assessment.
  • Price: standard price US$495; 50% discount. US$247.50.
  • Student ID: Upload a student ID during checkout to receive an additional 20% discount. Final student price: US$198.00.

Once payment is completed, the learner or professional will automatically receive the receipt, access instructions, username, and password to enter the course.

Course language:

English – Inglés, Spanish – Español, Portuguese – Portugués

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