What are the “Top 10 GMP Certificate Courses” you need to complete in 2023 if you’re one of the following life science industry professionals?
- A Quality Manager, Quality Associate, or Operations Team Leader
- Other personnel working in the pharmaceutical/medical devices or veterinary medicines industries, including but not limited to:
- Authorised Person(s) responsible for batch traceability & complaints management
- Manufacturing, operations and maintenance personnel
- Supply Chain Management & Logistics Personnel
- A drug development researcher, laboratory scientist, or Clinical Trial Sponsor
- A Pharmaceutical Industry IT support person or GxP System engineer/data analyst
- A Government Representative dealing with regulatory compliance matters
Top 10 GMP Courses You’ll Need This Year
Here are the ‘Top 10 GMP Courses’ (GxP & GMP education topics) recommended for you to complete in 2023 to stay on track with regulatory compliance matters.
- These GMP compliance courses are generally applicable to all regions/jurisdictions
- They are based on PIC/S GMP guidance & regulatory guidance from key Authorities including but not limited to the FDA, TGA, EMA, and others
This list is intended for individuals who are already working in the life sciences and pharmaceutical/medical device manufacturing sectors. If you’re a new graduate, you should complete a minimum of the first 6 courses listed below before you apply for job roles in the industry. Be sure to attach your GMP Course Completion Certificates to your CV if you’re considering a job change or requesting a promotion.
Top 2023 GMP Courses
- The following list includes links to self-paced, online GMP training formats that provide you with a Certificate of Completion for your GMP Training Records or CV
- Alternatively, review our instructor-led ‘classroom style’ GMP courses
- Onsite training and custom courses may be available for large groups of employees
#1 – Refresher Training for Good Manufacturing Practice (GMP)
#2 – Good Recordkeeping Practice (GRK) – Good Documentation Practice training
#3 – Data Integrity (DI requirements in GMP/GxP Environments) along with GxP Computerised Systems (to better understand PIC/S guidance & ISPE GAMP®5)
#4 – PIC/S Annexes Specific to your product type & GxP responsibilities
#5 – Supplier Qualification (Supplier monitoring & Supplier File content)
#6 – Management of Deviations & Non-Conformances (GMP Requirements)
#7 – CAPA Training (Corrective & Preventative Actions) – alternatively, you can register for a 1-day intensive ‘classroom style’ CAPA training session facilitated by Maria Mylonas
#8 – Pharmacovigilance (or Complaints Management, depending on your job role)
#9 – Recalls of Therapeutic Goods (covering Recall procedures for Pharmaceutical & Medical Device products)
#10 – PIC/S Annex 16 – Authorised Person & Batch Release (recently finalised by PIC/S)
Note: You can order individual training courses as needed. All prices are listed in US Dollars (USD).
However, there are also discounted bundles that let you ‘mix and match’ your Top 10 courses to suit your specific needs and product type! Click here to browse.
TOP 10 GMP Courses to Complete – Course Details
Course details and links below are for our online GMP e-Learning courses. Click here for a list of intensive 1-day GMP training courses delivered via Zoom and/or in classroom settings across Australia, New Zealand, & other regions around the globe.
GMP Education Topic #1: Foundations of Good Manufacturing Practice (GMP) in a ‘refresher’ learning format
Which GMP courses you should complete first in 2023 will depend on your existing GMP knowledge, as well as your career goals. Most GMP industry professionals will need to complete one or both of the following GMP education topics to ensure they understand the foundations of GMP compliance:
- Refresher Training for Good Manufacturing Practice (GMP) compliance, OR
- 10 Golden Rules of GMP (suitable for job-seekers, new GMP employees, or contractors and vendors who need an overview of the tenets of GMP)
Note: the ’10 Golden Rules of GMP’ course is often bundled with other training packages in discounted online GMP training packages, such as the Induction Auditing course package.
What if it’s been a long time since you’ve completed any formal GMP training?
- If you haven’t had formal/external GMP training in some time, you will likely benefit from completing GMP Part I and GMP Part II (covering APIs)
- These two courses help you to conveniently learn the basics of PIC/S GMP guidelines in the latest PIC/S Guides I & II (suitable for PIC/S Versions PE 009-15 & PE 009-16)
- f you work with sterile medicinal products, you will also need to complete PIC/S Annex 1
GMP Education Topic #2: Good Recordkeeping Practice (GRK)
Keeping good records is imperative for GMP & GxP compliance. Learn more about ALCOA+ and your recordkeeping responsibilities by taking the following course:
Good Recordkeeping Practice (GRK) is also called Good Documentation Practice (or GDocP). Note: the acronym for GDP is reserved for Good Distribution Practice.
GMP Education Topic #3: Data Integrity
Nearly every aspect of GMP compliance relies on Good Recordkeeping Practice (GRK). Yet ensuring your life science records are reliable, identifiable, consistently recorded, and trustworthy, is not necessarily adequate (on its own). Data must also be securely stored, appropriately backed up, yet readily accessible. You must also ensure organisation-wide compliance with Privacy laws and other GMP/GxP requirements for records.
To meet data integrity requirements, you must ensure Management implements and monitors appropriate data governance measures across the organisation.
Courses to help you understand your Data Integrity requirements include:
- Data Integrity (DI requirements in GMP/GxP Environments)
- Associated training courses, e.g.
- Option: Instructor-led intensive 1-day course on GMP Data Integrity requirements
GMP Education Topic #4: PIC/S Annexes Specific to your Product Type
- Click here for a list of PIC/S Annexes ranging from Sterile Medicinal Products to Advanced Therapeutic Medicinal Products (ATMPs) & Biologicals to Herbal Medicinal Products & more
- Includes courses specific to updated PIC/S Annexes including PIC/S Annex 1, PIC/S Annex 2A & Annex 2B, PIC/S Annex 13, PIC/S Annex 16, and others
GMP Education Topic #5: Supplier Qualification
Supplier Qualification compliance is especially important in 2023 after several years of pandemic-related supply chain disruptions, new product types & new suppliers entering the market, and greatly increased market demands. In fact, it’s a key target area during regulatory compliance inspections (GMP Audits).
Learn what’s required for your QMS/PQS procedures & Supplier Files in this handy online training course:
Why Supplier Qualification compliance training is particularly important:
The pandemic significantly disrupted existing supply chains in the life sciences industry. Pharmaceutical/medical device manufacturing companies had to scramble to secure necessary supplies and services, amidst increased demands. The result of these supply chain disruptions was:
- New product types and new suppliers rapidly entered the field
- Supply chain management expectations by Regulators were heightened in terms of ensuring supply chain security and stability
- Regulatory Inspectors/Auditors still demand well-documented evidence that you’re properly qualifying and monitoring your suppliers, and meeting industry risk management standards, including performing Supplier Audits & remote inspections (where expected)
This includes but is not limited to suppliers of your IT services/cloud-based services, computerised systems/software, equipment maintenance services, raw materials or intermediate products, packaging & labelling, warehouse & distribution services, and others.
GMP Education Topic #6: Deviations & Non-Conformances
Deviations, non-conformances, and out-of-specification results are not uncommon. This course will help anyone on your team understand what’s expected when a deviation or other quality incident occurs:
GMP Education Topic #7: CAPA
Corrective & Preventative Action (CAPA) Systems can be a minefield area for citations during GMP compliance audits. Find out how to manage your CAPAs in compliance with PIC/S GMP guidance in this handy online CAPA course:
- CAPA Training (Corrective & Preventative Actions) online OR
- Register for a facilitated ‘classroom’ style CAPA training session as a 1-day intensive (one of our most popular courses)
GMP Education Topic #8: Pharmacovigilance & Complaints Management
A must-know GMP education topic for business owners, Clinical Trial Sponsors, and Quality Management professionals alike, is ‘complaints handling’ (complaints management) as part of ongoing Pharmacovigilance. Learn what’s required for post-marketing product safety monitoring and adverse event reporting in these two essential Pharmaceutical Quality Management courses.
GMP Education Topic #9: Recalls
Everyone in your organisation should be trained in their product recall responsibilities.
The Recalls course (link below) will help you understand the importance of ensuring your recall SOPs are effective and up-to-date, that your employees are properly trained, and that you’ll be able to rapidly & effectively implement recall notices and actions as appropriate for the specific recall situation:
Example: While mock recalls are not expected by every Regulatory Authority, recall drills are often viewed by Regulators and businesses as a valuable exercise in order to:
- Ensure & demonstrate recall procedures are suitable and effective
- Train and prepare personnel to implement a product recall
- Evaluate the quality of your batch tracing records and storage & distribution data
GMP Education Topic #10: PIC/S Annex 16 – Authorised Person & Batch Release
PIC/S Annex 16 – Authorised Person & Batch Release – was a new Annex added to the latest PIC/S Guides. The Annex 16 course is based on PE 009-16, and is available at the link below:
GMP Compliance Resources: Other essential GMP presentations and training resources
- Preparing for a GMP Audit/GMP compliance inspection (e.g. FDA, TGA, EMA, etc.)
- Remote Auditing (an important course relating to post-pandemic supply chain management)
- FDA CFRs
GMP training for Pharmaceutical Industry Engineers & Cleanroom Architects
- Pharmaceutical Manufacturing Fundamentals including Product Containment, Contamination Control, HVAC, and Pharmaceutical Water Quality