Auditing and Compliance for Biopharmaceutical APIs:  Provides a thorough overview of current production and laboratory techniques for producing  biopharmaceutical APIs.  Also covers basic compliance requirements and techniques for conducting an effective audit.
	Compliance for Biopharmaceutical API Process Validation:  Describes requirements for a compliant process validation program and how to avoid major pitfalls and retain maximum efficiency.

 

API GMP Compliance:  Training on ICH Q7A.  Focuses on the specific, detailed FDA and international recommendations on how to apply GMPs that are missing from the more generic Finished Products regulations.

 

	Building in Compliance, Analytical Laboratories:  How to set up an Analytical Laboratory so it can be fully GMP compliant, yet still retain its efficiency.  Differences are pointed out for labs working on early phase clinical products vs. marketed products.
	Building in Compliance, Process Development: How to ensure that Process Development work can be captured in a GMP compliant manner so it can be used to support product filing claims and process validation.
	21 CFR Part 11 Compliance:  How to apply the Electronic Record and Electronic Signature regulations in your environment and key pitfalls to avoid.  Includes an overview of the regulation and how it applies to various applications, spreadsheets, network environments, etc.

 

Introduction to GMPs:  An introductory level course specific to biopharmaceuticals.