Regulatory - Cobblestone

IQ/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

CMC Writing and Submission Strategies

The CTD is the basis of drug, biologic, and drug-device combination registration applications. A proper understanding of CTD writing strategy and health authority expectations can greatly aid a company in gaining approval. With the prerequisite complete, this accredited training, will provide in-depth instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical… Continue reading CMC Writing and Submission Strategies

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

Good Laboratory Practices (GLP)

Benjamin Franklin famously said:Tell me and I forget, teach me and I may remember, involve me and I learn. This course has been entirely redesigned with this cogent observation in mind so that each person can get involved in problem-solving and thus learn about Good Laboratory Practice (GLP) Regulations. Overall, the main intent of this… Continue reading Good Laboratory Practices (GLP)

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

Pharmaceutical Process Development

This course is designed to provide a basic understanding of the significant process development effort involved in taking an R&D laboratory formulation to commercial production. This course will focus on two main areas: How to develop a pilot process suitable for scale-up to commercial production. Factors to consider during scale-up and technology transfer to take… Continue reading Pharmaceutical Process Development

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)