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.
Frank earned his BACE credential and found that it allowed him to easily transition into college-level research.