Taylor believes his BACE credential has given him an upper hand as a lab assistant and student researcher.
Documentation and Good Documentation Practices Common Documents There are over two dozen different types of documents used when working in a controlled environment. Although the contents vary from document to …
Who’s Who in the Company: Departmental Roles, Organization, and Communication Many biotech companies are very small at start-up, and employees may “wear many hats” (i.e. work as members of multiple …
CGMP IN A NUTSHELL Know what you are supposed to do before you do it. Document everything that occurs. According to the FDA, “if it isn’t documented, it didn’t happen.” …
21 CFR 211: The Ten Fundamentals of CGMP 1) Training – Subpart B: Organization of Personnel Employees must have the education and experience necessary to perform their assigned roles Personnel …
CODE OF FEDERAL REGULATIONS (CFR) The Code of Federal Regulations (CFR) is comprised of the general and permanent rules of the federal government. The CFR contains the official text of …
THE DRUG DEVELOPMENT PROCESS The complexity of drug development has greatly increased over the past 40 years. The process requires a preclinical phase of drug development, an investigational new drug …
Current Good Manufacturing Practices (CGMP) Current Good Manufacturing Practices are a system for ensuring that regulated healthcare products, such as drugs and medical devices, are consistently produced and controlled according to …
Biotility is excited to announce that the Biotechnician Assistant Credentialing Exam (BACE) has been added to the Texas Education Authority’s list of approved Industry Recognized Credentials (IRCs) AND approved by …
Abigail feels the BACE credential greatly helped boost her academic and scientific research experience and without it, she may not yet be where she is today.