2021 FDA Hot Spots for Regulated Life Science Industries

UL’s longtime CRADA relationship with FDA offers unique insight into their cGMP training expectations

UL’s Life Sciences division is built upon a foundation of our 21-year relationship with the U.S. Food and Drug Administration (FDA). Since 1999, UL and FDA have maintained a continuous Cooperative Research and Development Agreement (CRADA) to co-develop and deliver critical regulatory and compliance training to more than 36,000 FDA investigators worldwide.

This agreement was extended to 2024.

Together, we created a library of more than 200 life science elearning courses used by businesses and governmental bodies worldwide. FDA also utilizes UL’s ComplianceWire® learning management system (LMS) to manage federal, state and local investigator training and tracking.

ComplianceWire is UL’s best-in-class platform specifically designed for highly regulated industries. The LMS software automates the creation, delivery, and reporting of role-based training, qualification and compliance.

Also, 21 CFR Part 11 and EU Annex 11 compliant, our life science industry LMS is currently utilized by US and global pharmaceutical, medical device, biologic companies and global regulatory authorities.

To help satisfy regulatory compliance requirements, UL clients have access to identical FDA eLearning courseware, LMS delivery and tracking data.

What are FDA regulators’ cGMP competency training expectations?

UL has unique insight into what FDA may be prioritizing going forward, based upon the development of regulatory training curricula for its investigators.

Times have certainly changed and, in turn, so have the priorities for the FDA.

After more than 40 years of Life Sciences product development and regulatory guidance experience, I have consistently observed increasingly complex FDA expectations today, compared to when I served as a cGMP Training Manager at Pfizer.

Looking forward to 2021, we foresee that FDA is laser-focused on specifications for human behavior and competency, in addition to their product manufacturing and inspection scrutiny.

To meet these increasingly rigorous requirements, we recommend that life sciences professionals master these essential competencies prior to FDA inspections:

Timely training

They expect to see documented confirmation that the employee is up-to-speed and current in their role expertise and satisfies the position’s current requirements.

Assessment

Is the employee qualified for this role and what relevant expertise does he/she possess? What type of testing/evaluation have they completed to gauge competency, and what are the areas of strength and weakness? How are learning gaps being addressed?

Qualification

Critical competency areas should be reviewed and measured regularly through a continuous learning curriculum created specifically for each role.

Periodic re-qualification is essential, which can be achieved through refresher training, increasingly recommended quarterly by FDA. This training content should be centered on GMP weaknesses, rather than repeating previous professional development learning.

Continuous Training

Regulators in life science industries expect learning to be continuous. UL recently introduced   two refresher elearning courses, tailored specifically to the medical device and pharmaceutical industry, to retrain employees on the essential importance of a sound quality system and culture throughout their organization:

  1. Medical Device Quality System and Quality Culture

This course reviews the quality system and culture for medical device manufacturers.

Topics: Subsystems of the QSR, Management Responsibility and Risk Management, and Developing a Quality Culture.

Outcome: Learners will be able to identify the seven principal subsystems and objectives of the medical device Quality System Regulation and recognize how a robust quality culture can support the effective execution of Quality Systems.

cGMP Refresher: Medical Device Quality System and Quality Culture

  1. Pharmaceutical Quality System and Quality Culture

This course provides an overview of the Pharmaceutical Quality System (PQS) and addresses the importance of a quality culture.

Topics: Elements of the PQS, Management Commitment, and Developing a Quality Culture.

Outcome: Learners will be able to identify the elements and objectives of the Q10 Pharmaceutical System and recognize how a robust quality culture can support the effective execution of Quality Systems.

cGMP Refresher: Pharmaceutical Quality System and Quality Culture

Looking forward: FDA’s top five GMP inspection targets

FDA’s priorities change to meet and exceed the demands of an ever-evolving industry. Through our direct relationship, in tandem with feedback from UL’s biopharma, medical device and healthcare clients, we have identified five distinct themes that we project FDA will be prioritizing in 2021 and beyond:

  1. Data integrity (DI)

One in three warning letters are related to DI issues. FDA has identified data that is not secure, controlled, or inadvertently or deliberately falsified. Facility inspections outside the US have increased a whopping 70 percent over the past five years.

Suggested UL Data Integrity courses:

  • Introduction to Data Integrity (DATA01)
  • Auditing of Computer System Validation to Ensure Data Integrity (DATA02)
  • Data Integrity: The Role of Quality Assurance for Data Integrity (DATA03)
  • Data Integrity for Quality Control Laboratories (DATA04)
  • Data Integrity for Clinical Research Staff (DATA05)
  1. Quality management systems

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction.  QMS spans the entire product lifecycle from clinical through product realization stages. FDA’s inspection focus has significantly increased.

Suggested UL Quality Systems courses:

  • Q10 Pharmaceutical Quality System (ICHreg07)
  • Introduction to the Quality System Regulation (DEV43)
  • ISO 9001: 2015 (DEV61)
  • ISO 13485: 2016 DEV48 /DEV50 (2 courses)
  1. Sterile manufacturing

Product contamination and unsterile worksites are chronic challenges that haunt many Life Sciences organizations. Aseptic processing is stubbornly complex to control successfully. Frequent training and retraining in this critical area is essential.

Suggested UL Sterile Processing courses:

  • Principles of Aseptic Processing (PHDV71)
  • Principles of Sterilization (PHDV81)
  • Basics of Cleanroom Operations (Aseptic01)
  • Sterile Dosage Forms Introduction (Aseptic02)
  • Principles of Restricted Access Barrier Systems and Isolators (Aseptic03)
  • Isolators for Aseptic Processing (Aseptic04)
  • RABS for Aseptic Processing (Aseptic05)
  • Media Fills for Aseptic Processing (Aseptic06)
  • Dos and Don’ts of Aseptic Environments (Aseptic07)
  • Cleanroom Cleaning, Sanitization, and Disinfection (Aseptic08)
  1. Risk management

Risk has expanded beyond the medical device industry into pharmaceuticals and healthcare. FDA has consistently identified poor error investigation and deviations from procedures, resulting in greater likelihood of continuing unchecked errors.

Suggested UL Risk Management courses:

  • Risk Management: Key Concepts and Definitions (FDA29)
  • Risk Management for Pharmaceutical Manufacturers (PHA72)
  • ICH Q9 Guidance: Quality Risk Management (ICHreg05)
  • ISO 14971: Risk Management for Medical Device (DEV55)
  1. FDA inspection readiness

Surprisingly, comprehensive preparation for an inspection is often presumed to be satisfactory, only to discover a critical process or document is not in place. Is your current team adequately prepared for a scheduled or surprise inspection in the next few weeks (or days) by FDA? Are quality systems and documentation updated, well maintained and compliant with 21 CFR Part 820? How do you manage the overall inspection and how do you judiciously prepare staff for this critical event?

Suggested UL FDA Inspection Readiness courses:

  • Awareness of FDA Inspections (PHA65)
  • Handling an FDA Inspection (PHDV74)
  • Pre- and Post-Approval FDA Inspections (PHA75)
  • Effectively Responding to FDA 483’s and Warning Letters (PHDV70)
  • Preparing employees to interact with FDA Inspectors (classroom)

Visit UL’s extensive elearning course list:

UL CREATE:  Personalize your GMP courseware for company-specific learning

Create self-authoring software allows you to personalize hundreds of UL off-the-shelf training courses, including our GMP suite of online learning, to meet your proprietary training requirements, in multiple languages, if necessary.

Once completed, these mobile-friendly courses will automatically adapt to the digital device used by your learner–tablet, smartphone, laptop or desktop—at any time, in any location with an internet connection.

UL Create allows you to simultaneously work with authoring partners around the world with the learning software’s collaboration tools and approval process workflow for content editing and QA collaboration.

Courses can be published directly to the ComplianceWire LMS, or seamlessly integrated with any AICC, SCORM and PENS-compliant learning management systems.

Partnering training curricula with modern learning styles, such as micro learning and blended learning, employee training methodologies have never offered more opportunities to achieve excellence.

UL’s best-in-class eLearning supports FDA’s cGMP practices

UL is proud of its global reputation partnering a plethora of Life Sciences training courses with modern learning techniques to boost employees at all levels to achieve excellence.

Our goal is to provide your organization with the tools to develop confident employees who have achieved job qualification, compliance and competency.

The fluid nature of the medical device, pharmaceutical and healthcare industries demands a commitment to promoting continuous learning, using various digital devices, day or night, reaching all corners of the world.

Emboldening your personnel with an arsenal of high-quality learning tools and opportunities inspires them to continuous improvement while inspiring those around them.

Our highly-qualified subject matter experts and instructional designers specialize in employee development curricula to satisfy FDA requirements, surpass compliance to achieve competency and measure qualification to dramatically reduce error risk.

To learn more about UL Life Sciences GMP courses and ComplianceWire learning management system, call +1.609.627.5300 to speak with one of our LMS product specialists. Visit ulehss.com.