The research, development, manufacturing, and regulatory approval of new biotechnology and biopharmaceutical products often presents novel challenges for which a background in conventional pharmaceuticals offers little guidance.
To bridge this gap between academic instruction and the real-world complexities of research, development, validation, regulations, processing, and manufacturing, we provide practical, specialized training by industry experts. With ever-changing scientific understanding and government regulations, it’s critical that you have the most current information possible – training with COBBLESTONE ensures you will.
GMP Change Control Process
Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many… Continue reading GMP Change Control Process
Read MorePrecision Tools for Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be managed,… Continue reading Precision Tools for Error Reduction
Read MoreIntroduction to Validation Principles, Practices and Requirements
FDA-regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This training course provides an overview and introduction to Validation principles and requirements. Process validation, Computer System Validation, Cleaning Validation, Methods Validation, Qualifications, and Validations Project Management are all topics discussed in… Continue reading Introduction to Validation Principles, Practices and Requirements
Read MoreWriting Effective Regulatory, Medical and Technical Documents
The success of a company’s drug product or medical device regulatory submission is heavily dependent on the quality of its documentation submitted to regulatory authorities. Therefore, crafting precise, concise, well-referenced, and unambiguous technical documents is vital for business success. To produce such high-quality documents, effective writing skills must be continually honed. In this accredited course, you will… Continue reading Writing Effective Regulatory, Medical and Technical Documents
Read MoreIntroduction to CAPA Management
There have been several form 483s and warning letters being issued to companies by the FDA as it relates to CAPA investigation because of insufficient or incomplete quality systems procedures applicable to Corrective Action and Preventative Action programs (CAPA). Addressing an FDA form 483 with findings associated with CAPA systems must be performed adequately, complete… Continue reading Introduction to CAPA Management
Read MoreIntroduction to Batch Record Review
Regulatory agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process to demonstrate compliance. A strong batch record review system is essential in order to properly document all critical and operational process parameters… Continue reading Introduction to Batch Record Review
Read MoreAn Introduction to Oral Solid Dosage Form
The most common pharmaceutical dosage is the oral solid dosage form, which includes both tablets and capsules. There are many different ways to manufacture these products, starting with the appropriate selection of excipients all the way through the production of the finished product. Ultimately, the successful production of a tablet or capsule is dependent upon… Continue reading An Introduction to Oral Solid Dosage Form
Read MorecGMPs for Biologics
This intensive training will provide an oversight into cGMPs for biologics and large-molecule manufacturing, from development to engineering batches to Process Performance Qualification (PPQ) lots including analytical method validation. A review of vital and current Biopharmaceutical/Biologics processes will be conducted for current Quality/Regulatory expectations. Key insights are presented for both FDA and EU regulatory requirements, with crucial… Continue reading cGMPs for Biologics
Read MoreLaura Jeannel
Laura Jeannel is a Senior Quality Consultant for Farbridge Pharma Consulting, is an experienced Quality Assurance professional, leading as a former Quality Director and key consultant for over 20 years. During her career, she has led major pharmaceutical companies in establishing, executing, and continuous improvement for sustainable Quality Management Systems. Ms. Jeannel has been responsible… Continue reading Laura Jeannel
Read MorePharmacopoeia Compliance: An Overview [FREE WEBINAR]
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry. Ensuring pharmacopoeia compliance is often complex and the… Continue reading Pharmacopoeia Compliance: An Overview [FREE WEBINAR]
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