Medical devices span the therapeutic spectrum, from the toothbrush to life-saving heart implants. Even in simple devices, complex engineering challenges can arise that must balance mechanical, biological, regulatory, and other factors.
Frequent training is necessary to stay current on the practical demands of adhering to medical device regulations and validation processes, and helps ensure your manufacturing process will produce devices that conform to the approved design characteristics.
Packaging Process Validations
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
Read MoreHow to Conduct Robust Root Cause Investigations for CAPA
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of a sub-standard product, or product recall. Furthermore, costly… Continue reading How to Conduct Robust Root Cause Investigations for CAPA
Read MoreIntroduction to Pharmaceutical Quality Management Systems
This accredited online training course describes the requirements of an effective, comprehensively designed and correctly implemented Pharmaceutical Quality Systems (PQS) that incorporates Good Manufacturing Practice, Controls, Continuous improvements, and Quality Risk Management. All parts of the PQS should be adequately resourced with competent personnel, suitable and sufficient premises, equipment, facilities, processes, and effective procedures. This… Continue reading Introduction to Pharmaceutical Quality Management Systems
Read MoreBasic 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
Read MoreQualification 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)
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
Read MoreSterile Products
Parenteral product development and aseptic manufacturing can be intimidating to people new to the topics. The approach to formulation and process development is substantially different than for oral and topical medications. Product development and manufacturing must consider how all of the manufacturing processes align to ensure chemical, physical, and microbiological stability with particular attention to… Continue reading Sterile Products
Read MorePackaging Pharmaceuticals, Medical Devices, and Combination Products
The importance of a product’s primary package cannot be overstated. From material selection to closures to stability to the packaging process itself, a multitude of critical decisions must be made in order to develop a quality package. Shortcomings or a lack of understanding of any of these important considerations can render a final package unacceptable.… Continue reading Packaging Pharmaceuticals, Medical Devices, and Combination Products
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 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
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