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Thinking Outside of the GMP (Good Manufacturing Practice) Box Training Course

In this 2-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

10-11 September 2024
+ 14-15 January 2025, 13-14 May 2025 »

from £1099

Need help?  Enrol or reserve

Course overview

When you look at the bigger picture by taking a few steps back, it is possible to see that GMP, which we have difficulty in implementing from time to time, can actually be evaluated from different perspectives and will turn into a situation that gains even more value. This training course has been specially prepared to serve exactly this purpose.

In the rush to fully meet the striking technological developments and inventions in the pharmaceutical industry; the expectations of the health authority; updated guidelines; and the needs of the end-user patient, we can do no more than try to strictly comply with GMP regulations. We tend to consider our company as 100% GMP compliant when we fulfil the obligations of local or international GMP guidelines and directives. 

In this training course, the topics will be examined with a very different perspective, enabling you to refresh your existing knowledge and learn new expertise on the subject. After the sessions, your GMP knowledge will be maximised with scenario studies and bonus complementary documents will also be given in addition to the training presentation. 

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

  • Gain an insight into top management's approach to risks
  • Learn the training and documentation system, including planning GMP trainings and process mapping tips
  • Understand the personnel selection criteria in accordance with GMP
  • Explore GMP compliant lateral-thinking techniques, behaviour change models in GMP and the mechanisms to prevent errors in sampling and validation
  • Ensure cost reduction tactics in validations
  • Adapt lessons learnt from other sectors to GMP

Who should attend

Personnel who are in a wide range of GMP-related jobs will benefit from this course, including those in:

  • Quality Assurance
  • Quality Control
  • GMP Compliance
  • Validation
  • Engineering
  • Operation
  • Manufacturing
  • Supply Chain
  • Logistics
  • IT
  • Purchasing

Enrol or reserve

The Thinking Outside of the GMP Box course will cover:

Introduction to GMP regulations

  • What is GMP?
  • International guidelines and directives for GMP

Management responsibility

  • Who are 'Top Management'? Can we reach them? 
  • What are the main responsibilities of 'Top Management'?
  • How does 'Top Management' approach and manage risks?
  • Do they ask smart questions on the shop floor?

Lessons learnt from other industries

  • GMP excellence by design
  • Aviation and Automotive industries best practices
  • The 'learning by doing' approach in a regulated environment

Learning organisation and quality culture

  • What is knowledge management?
  • Do we learn effectively what’s taught?
  • Is it different than that  of Quality Risk Management?
  • Quality culture in Pharma and Biotech Industries
  • Which one is the best? Company culture or quality culture?

Personnel and training expectations in GMP

  • How to simplify trainings without compromising GMP rules
  • How to select and qualify personnel
  • Aligning job descriptions with cGMP
  • How to deal with passengers in a QC Laboratory
  • New employee orientation program structure
  • Proven tactics of keeping the GMP training records
  • What are the 10 training errors?

Documentation pitfalls

  • How to simplify documentation without compromising GMP rules
  • Real dangers behind data integrity applications
  • How to handle data for GMP expectations
  • How to reduce or eliminate documentation errors
  • How do you ensure data integrity during validation?

Group exercise: let’s improve our SOPs in microbiology laboratory

Deviation management and CAPAs

  • How to simply handle deviations by asking lateral questions
  • Who is responsible for the deviation or OOS?
  • Sophisticated PAs approaches
  • Where’s CA gone?
  • Why is it so exhaustive to find the true root cause?

GMP behaviour models

  • How to change old GMP behaviours
  • Why multitasking is lurking somewhere in GMP compliance
  • Four magic words for GMP Compliance
  • Eliminating the non-value-added activities form GMP

A new validation approach

  • How to handle deviations in cleaning and process validation
  • Is it possible to reduce the costs in validation activities?
  • How to prevent sampling errors in validation
  • How to simplify Computerised System Documentation? (Computer Software Assurance and GAMP5-Second Edition)
  • Successful QC integration with GMP compliance

Knowledge-based change control

  • What knowledge-based Change Control is
  • Change Control vs. Change Management
  • How to adapt QRM to changes
  • How to avoid pitfalls in CC
  • How frequently to monitor the effectiveness of changes
  • FDA 483s for Change Control

Before and after shutdown

  • Things to do before and after facility shutdown
  • Do we have to repeat Aseptic Process Simulation?
  • What are the main responsibilities of the Engineering department during the shutdown period?
  • How to switch from preventive maintenance to predictive maintenance
  • How robust are our Critical Utilities (HVAC, Water, Steam, Gas) according to current GMP Guidelines?

Complaints and recalls

  • What is risk-based recall management?
  • Who manages complaints in your company?

Group exercise: audit shortcuts

Technology transfer best practices

  • How to manage aseptic product technology transfer?
  • What are the main pillars of GMP compliant test method transfer?
  • How to prevent drug shortages without compromising GMP Expectations?

Outsourcing

  • How to find the most appropriate Quality Agreement template
  • Effective tactics to manage Quality when outsourcing
  • What lessons to learn from Heparin and other crises

Do you know your GMP compliance score?

  • Is it possible to achieve 100% GMP compliance?
  • How to implement a gap analysis to detect quality problems
  • Do you know how to measure your GMP performance?
  • How elegant is your GMP system?
  • How to spot weakness in GMP compliance?

Enrol or reserve

Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.  

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry. 

He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.

While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.

He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named “Good Distribution Practices” and his new book on ‘GMP Audits in Pharmaceutical and Biotechnology Industires’ will be published by Taylor & Francis in June 28, 2024.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

10-11 September 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15198

  • GBP 1,099 1,299
  • EUR 1,569 1,849
  • USD 1,786 2,098

Until 06 Aug

View basket 

 
Not ready to book yet?

for 7 days, no obligation

14-15 January 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15199

  • GBP 1,099 1,299
  • EUR 1,569 1,849
  • USD 1,786 2,098

Until 10 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

13-14 May 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15200

  • GBP 1,099 1,299
  • EUR 1,569 1,849
  • USD 1,786 2,098

Until 08 Apr

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy