The QbD Toolbox
If you are charged with exploring or implementing a QbD effort within your organization, where do you begin? Available guidance documents do not provide all of the information necessary to effectively implement such a program. Without proper understanding of how to establish QbD, your efforts may fail. This accredited training course presents methods that assist… Continue reading The QbD Toolbox
Read MorePackaging Process Validations: Pharmaceutical & Medical Devices
The integrity of a package depends on the qualification of the packaging equipment, the packaging process, and consistent performance throughout the commercial packaging run. No matter how well the container/closure has been developed, it cannot protect the product as designed if it is not properly sealed and packed. The packaging process validation ensures that packages… Continue reading Packaging Process Validations: Pharmaceutical & Medical Devices
Read MoreIQ/OQ/PQ
The Installation/Operational/Performance Qualification (IQ/OQ/PQ) of equipment, systems and facilities for sterile, oral solid dosage forms, liquids, finished and bulk drugs in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process. Equipment and systems must be installed, operated, and maintained within design specifications and facilities must be accepted as fit… Continue reading IQ/OQ/PQ
Read MoreGMP 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
Read MoreSterilization 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
Read MoreGMP 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
Read MoreFDA 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
Read MoreStarch 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
Read MoreDrug 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
Read MoreWriting 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
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