Intermediate

Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable to avoid costly errors, batch disposal, expensive failure… Continue reading Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

GMP Laboratory Control Professionals Certification Program

In their own Guide to Inspecting Quality Control Laboratories, the FDA states: The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. Accurate, reliable, and meaningful laboratory data is… Continue reading GMP Laboratory Control Professionals Certification Program

Sterilization Professionals Certification Program

In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that manufacturers of… Continue reading Sterilization Professionals Certification Program

GMP Professional Certification Program

Earn Your GMP Professional Certification Cobblestone’s GMP Professional Certification Program will provide you with the necessary orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical products. You will be trained in the understanding and interpretation of the FD&C Act, the cGMPs, the FDA Guidance Documents, and FDA’s recent observations in FD… Continue reading GMP Professional Certification Program

FDA Inspection Readiness Certification Program

The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading FDA Inspection Readiness Certification Program

Starch Technology

Starch is a recognized natural hydrophilic polymer that is popularly utilized in various kinds of formulations as a swelling agent and gel forming excipient. It has multiple structural arrangements and functionalities. This accredited course will cover the science and operational aspects of products using starches, which are amongst the most important ingredients used in a… Continue reading Starch Technology

Drug Product Stability and Shelf-Life

Every drug product must undergo sufficient stability testing before it can be introduced to the market. While ICH has standardized and harmonized the stability testing process, there are still numerous challenges that need to be addressed to ensure that stability testing is conducted accurately. Inadequate stability testing can cause delays in product introduction, which is… Continue reading Drug Product Stability and Shelf-Life

Writing and Enforcing SOPs: Best Practices for Regulated Industries

Organizations often face challenges when creating and enforcing effective standard operating procedures (SOPs). Poorly written SOPs are a common cause of deficiencies and observations mentioned in 483s and warning letters issued by the FDA. Therefore, companies operating in regulated industries must understand how to organize and present information for the intended audience and purpose. To address… Continue reading Writing and Enforcing SOPs: Best Practices for Regulated Industries

Qualification and Management of CMOs (Contract Manufacturing Organizations)

Every pharmaceutical company hopes to obtain its desired expectations when it comes to important relationships with their outsourcing partners. This intensive course examines the root causes of critical issues that can arise within these relationships, which are much broader and deeper than the technical capability to perform a process. This course examines the strategic and… Continue reading Qualification and Management of CMOs (Contract Manufacturing Organizations)