Insights

14
May
2019

Establishing CMC Regulatory Compliance Readiness: When Research Outpaces Regulation

Compliance strategies for biopharmaceuticals and biosimilars are based on five pillars of excellence: The first, that the strategy takes into account the full scope of Chemistry, Manufacturing and Controls activities.
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07
May
2019

Optimize Your Process, Optimize Your Career: Become a Quality by Design (QbD) Certified Professional

QbD is a comprehensive system for designing experiments that focuses on quality and reliability from the beginning of drug development. Ensuring your processes receive FDA Certification requires careful planning and stewardship. Pharmaceutical professionals who are certified in QbD are in well-placed for career advancement in both domestic, international and emerging markets.
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23
Apr
2019

Data Integrity: The Next Step in Computer System Validation

In our Computer System Validation course, offered May 20-21 in London, our instructors will discuss key concepts in computer system validation including FDA regulations, non-compliance issues that can result in warning letters, and implementing a practical-but- defensible computer validation system for your development programs. While these foundational topics are excellent for those who are new to data validation and equipment regulations, it’s important in this industry to stay abreast of new technological developments that can ensure the success of your drug development projects.
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16
Apr
2019

Fast-track to a Great Career: Earn Biotechnology Certification

A recent report from the IMARC Group showed that the market for testing pharmaceutical products has seen steady growth and will continue to growth through 2024. Where there is market growth, there are great careers to be had for eager professionals, whether new grads or those already working in the pharmaceutical and biotech industries. Adding a biotechnology certificate to your credentials sets you apart in the job market, and ensures your skills are in high demand.
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09
Apr
2019

Stability Test Chambers Market Forecasted to Grow as Regulations for Accurate Product Shelf Life Testing Tighten

An essential component of good manufacturing practices, stability testing can be the make-or-break step in the manufacturing process. FDA guidelines determine which standards for shelf life a drug must meet, including humidity and temperature controls, but all testing must happen in a controlled environment for valid results.
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02
Apr
2019

How the GDPR Affects the Medical Device Industry

Like many industries, the medical field is becoming more and more reliant on information and analytics to improve their services and find better ways to serve the public. But complying with data protection means more than just passwords and virtual locks, especially for an industry that intends to take care of the physical and mental well-being of humans.
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26
Mar
2019

Preparing for Annual Product Quality Reviews: Good Manufacturing Practices Training

One of the most important times of the year for professionals engaged in Good Manufacturing Practices quality assurance, the annual product quality review as mandated by the FDA allows your business to ensure not only compliance with FDA regulations, but also ensure the best quality products that carry your brand name are on the market.
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19
Mar
2019

Creating GMP-Grade CBD: Drug Developers Eyeing Synthetic Cannabinoids

The cannabis industry is already making big waves and big money in the U.S. in spite of being legally available in only a few markets. In 2016, the U.S. industry alone was estimated to be worth $7.06 billion and is forecasted to grow rapidly by 2025.
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12
Mar
2019

CMC Certification: Staying on Top of New Developments in Gene Therapy

For CMC certified professionals, the importance of being up-to-date in your field cannot be underestimated. New drug and biologic developments occur at a rapid pace, and lack of awareness could be costly for decision-makers with compounds under development or in review.
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05
Mar
2019

Changing eCTD Submission Requirements: What You Need to Know

Since 2015, the FDA has required certain types of submissions to follow the eCTD format, and has slowly rolled out the requirement to other channels. Even though the deadline for conversion to eCTD for Type III Drug Master Files (DMF) applications has been extended to May 5, 2020, it is still very much in progress, and pharmaceutical professionals must be aware of the constantly changing requirements and evolution of the document format itself.
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26
Feb
2019

Report: The Contract Biomanufacturing Services Global Market

Released in December of last year, a new report forecasts the global CMO market to 2027 and discusses the impacts of increased partnering with contract organizations, the risks and potential opportunities that biopharma companies need to know now in order to be a key player in this $13.3 billion market.
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19
Feb
2019

Quality System Regulation: Reflecting on CAPA Procedures

Our training program (QSRCP) Quality System Regulation (QSR) Certified Compliance Professional™ is designed to demystify the complex regulatory policies of the FDA for Quality System Regulation, a process with some many moving parts that pharmaceutical and medical device manufacturers find themselves in a maze of stumbling blocks. Non-compliance is costly in terms of time and money, and quality system regulation touches every stage of development.
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12
Feb
2019

Press Release : CfPIE Introduces New Advanced Blockchain Concepts for the Pharmaceutical and Medical Device Industries

The Center for Professional Innovation and Education (CfPIE) is pleased to announce that they will offer a new training program geared towards improving security and data storage for clinical trials and the R&D pipeline. Life Science professionals wishing to prepare in advance of the 2023 FDA Drug Supply Chain Security Act will greatly benefit from attending the Advanced Blockchain Concepts for the Pharmaceutical and Medical Device Industries on May 13-14, 2019.
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05
Feb
2019

The Consequences of Non-Compliance in Computer System Validation

An essential piece of the R&D puzzle, computer systems are not only storage places for data in pharmaceutical development, but have become the sites of quality control, automation, and feedback that aids in decision-making throughout the lifecycle of your business.
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29
Jan
2019

New Directions in Pharmaceutical Development: Preparing for the AI Future

Artificial intelligence is a topic gaining traction across many industries, not least pharmaceutical development. The benefits are obvious: AI can process huge amounts of data, eliminate human error in repetitive tasks and apply checks and balances to systems where our human memory fails. But there are also risks associated with implementing AI studies that need to be explored by qualified pharmaceutical development professionals.
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22
Jan
2019

Evaluating CROs: How to Ensure Good Laboratory Practice Measures are in Place

As of 2017, there were more than 1100 contract research organizations (CROs) operating globally, in an industry expected to grow at a rate of 7.6% between now and 2023. Some of these research organizations are one-lab specialists studying the impact of new pharmaceutical compounds on particular systems or organs, while others are multinationals who strive to be full-service, one-stop shops.
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15
Jan
2019

Good Manufacturing Practices: The FDA’s Year in Review

In December of 2018, the FDA released a report: Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This communication replaced the 2014 guidelines, and included several updates to protocol. Among these were testing for shelf-life and stability of medications, storage of reserve samples in the lab, and crucially, differentiating between sterile and non-sterile drug compounds in storage and other considerations.
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08
Jan
2019

Biopharmaceutical Courses for the Pharmaceutical Professional

Whether you’ve been in the industry many years or are a new entrant into the field, those in the pharmaceutical industry know that biopharmaceuticals are the wave of the future, and indeed are experiencing steady growth not only in America, but worldwide as well.
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24
Dec
2018

How to Avert Disaster: (CMCCP) Chemistry, Manufacturing & Controls (CMC) Certified Professional™ Chemistry Certification

Just this week, biotech company DBV Technologies learned a harsh lesson in proper CMC protocol, as they were forced to withdraw their approval application of Viaskin Peanut, a peanut allergy treatment targeting children 4-11 years old. The FDA cited chemistry, manufacturing and controls issues as their reason for their rejection of DBV’s biologics license application, causing the company’s stock to drop a staggering 67.4%.
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