Inspection Readiness

Inspection Readiness Training

Ensuring a successful inspection, from small business distributors to well-established global sponsors and manufacturers alike, requires preparation and an understanding of industry practices. This informational course provides an overview of regulatory inspection processes, targeted industry-specific guidance, and important references and links to regulations and guidelines that will allow your team to prepare for regulatory authority inspections (including the FDA and European Medicines Agency).

Over 14 weeks, those taking the course will learn details from industry experts and former regulatory authority personnel on what to expect during an inspection and how to maneuver to a successful closing meeting and beyond. This is an excellent program for establishing a broader knowledge-base on expectations, preparing procedures, communication strategies, and maintaining control over the inspection process.

Who Should Take This Course

Those involved in regulatory inspections and those preparing for an inspection in the pharmaceutical, biotechnology, medical device, or biologics industry would greatly benefit from this program. This course provides soft skills for improved site-inspector communication and common terminology used by regulatory authorities when addressing outcomes and enforcement. At the end of this course, professionals will have gained knowledge of regulations and guidance impacting inspections, compliance and enforcement, as well as soft skills, industry standards, and terminology involved in inspection.

Mini Courses

Separate mini courses have been prepared with consideration for a variety of specific industries. These courses are shorter than the main Inspection Readiness course, consisting of 3-4 modules each instead of all 14. These are for professionals with specific inspection needs.

Below is a list of the mini courses, the specific industry the course will cover, and who should take which course.

Clinical Investigator Inspection Readiness

In this three-module course, professionals will gain an understanding of the clinical site inspection process, how a site can prepare, the logistics of remote and on-site inspections, and guidance on how to respond to inspection findings. This has been designed for professionals looking for an overview of the inspection process.

Sponsor/CRO Inspection Readiness

Professionals will learn about inspections of clinical research organizations (CROs) and clinical trial sponsors, the logistics of remote and on-site inspections, and guidance on how to respond to inspection findings over the course of three modulesIt was created for professionals looking to learn about Sponsor/CRO inspection readiness specifically. 

GMP Drug and/or Biologics (CMO/Manufacturer) Inspection Readiness

Consisting of three modules, this course is ideal for professionals looking to learn about inspection readiness for the GMP Drug and/or Biologics CMO/Manufacturers specifically. It will cover good manufacturing practices (GMP) relating to drugs and biologics, information on their history, what they are, and how to comply. Information on the logistics of remote and on-site inspections and guidance on how to respond to inspection finding is also included. 

GMP Device (CMO/Manufacturer) Inspection Readiness

Professionals looking to learn about inspections for the medical device CMO/Manufacturers will benefit from this three-module course, which covers good manufacturing practices (GMP) relating to medical devices, information on their history, what they are, and how to comply. It also includes the logistics of remote and on-site inspections and guidance on how to respond to inspection findings. 

GMP Combination Product (CMO/Manufacturer) Inspection Readiness

Over the course of three modules, professionals will gain an understanding of good manufacturing practices relating to both drug/biologics and medical devices, information on their history, what they are, and how to comply. It will also cover the logistics of remote and on-site inspections and guidance on how to respond to inspection findings. This is a great option for professionals concerned with inspection readiness for the drug/biologics and medical device CMO/Manufacturers specifically. 

GCLP (Safety/Clinical Laboratory) Inspection Readiness

Those looking for an understanding of inspections of clinical or safety laboratories will benefit from this three-module course covering good clinical laboratory practicesthe logistics of remote and on-site inspections, and guidance on how to respond to inspection findings. 

GLP (Animal Laboratory) Inspection Readiness

Created for professionals working in animal laboratories, this course will cover good laboratory practices, information on their history, what they are, and how to comply over the course of three modules. It will also provide information on the logistics of remote and on-site inspections and guidance on how to respond to inspection findings. 

Bioanalytical/Pharmacokinetic Laboratory Inspection Readiness

In this threemodule course designed for professionals looking to gain an understanding of inspections of facilities that are conducting BA/BE/PK studies, how best to prepare for these inspections, the logistics of remote and on-site inspections, and guidance on how to respond to inspection findings will be covered. 

Phase 1 Unit (Clinical Investigator, Bioequivalence) Inspection Readiness

This course consists of four modules with the option to add an additional module if a professional is interested in pharmacovigilance responsibilities, monitoring or other clinical CRO responsibilities, or safety/clinical laboratory responsibilities. For those looking to learn about inspection readiness for clinical sites and facilities conducting BA/BE/PK studies specifically, how best to prepare for these inspections, the logistics of remote and on-site inspections, and guidance on how to respond to inspection findings will be covered. 

GDP/GSP (Distributors and Storage Depots) Inspection Readiness

Professionals will gain an understanding of inspections for distributors and storage depots specifically, with information on good distribution and supplier practices, information on their history, what they are, and how to comply is included in this three-module course. Information on the logistics of remote and on-site inspections and guidance on how to respond to inspection findings will also be included. 

GVP (Pharmacovigilance) Inspection Readiness

Over the course of three modules, professionals looking to learn about inspection readiness for GVP processes specifically will learn about inspections being conducted by or on behalf of the sponsor, the logistics of remote and on-site inspections, and guidance on how to respond to inspection findings. 

Remote Inspection Basics

This two-module course will cover the basics of remote inspections and guidance on how to respond to inspection findings, and is for professionals looking to gain an understanding of remote inspections specifically.

Regulatory Agency (FDA/EMA/MHRA) and ISO Basics

For professionals looking to understand the basics of regulatory agencies, this course provides a high-level overview of the various regulatory bodies that oversee the inspection process, a background on the purpose of inspections, and the ISO certification process over the course of three modules. Professionals will also receive guidance on accessing, reading, and understanding of Regulations, Guidance Documents, and Compliance programs for the FDA, MHRA/EMA, and ICH.  

Post Inspection Management/Response

In this one module course, professionals will receive guidance on how to respond to inspection findings, which is excellent for professionals looking to learn about inspection follow up only. 

Meet Our Instructor 

jennifer perrin

Jennifer Perrin has over 20 years of experience in regulatory compliance, and currently works as Manager of Quality and Compliance at MMS. She works to ensure outstanding services meet regulatory requirements and highquality standards.  Before coming to MMS, she spent over 20 years working in regulated industries focusing on quality management systems, and her expertise lies in GMP, Supplier Quality Management, Auditing, and Validation activities.

 

LEARN MORE

Clinical programming

DURATION & PREREQUISITES

A total of 14 weeks is needed for completing the full program. 3 to 4 weeks are needed for mini course completion.  

Education and/or Experience 

Recommended 2 years in pharmaceutical, medical device, or biologics industry, or similarly regulated field.  

Minimum Expectations 

  • An understanding of pharmaceutical, medical device, or biologics industry, or similarly regulated industry.  
  • Must have strong understanding of Microsoft Office® 
  • Strong desire to understanding regulatory inspections and the regulatory environment.  

Assessments 

Evaluations based on the information will be assessed through a quiz for each module. A minimum of 80% is required to pass each quiz.  

CONNECT WITH ADMISSIONS

11 + 9 =

MMS Academy

facebook  YouTube  LinkedIn

CONTACT US

4 + 14 =