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Certified Pharmaceutical & Biotechnology GMP & GDP Lead Auditor- ONLINE/ LIVE

June 16 - June 18

USD3500

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https://www.qualityacademia.com/gizlilik/
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EXPANDED CONTENT NOW ACCORDING TO NEWLY PUBLISHED EU, PIC/S GMP ANNEX 1, FDA COMPUTER SOFTWARE ASSURANCE GUIDELINES.

OUR PARTICIPANTS WILL BE ENTITLED TO RECEIVE DOUBLE LEAD AUDITOR CERTIFICATES

This ONLINE training has been prepared for professional people who will be actively involved in 1st , 2nd  and 3rd  Party audits. The aim of the training is to train the Lead Auditor to manage the audits to be carried out according to international and local GMP guidelines and directives. The training was created on the basis of all quality management systems implemented in the pharmaceutical, biotechnology and medical device sectors. The duties and responsibilities of the lead auditor, the planning, announcement, realization, reporting and follow-up audits of the audit are supported by role play, case study and scenario studies.

Unfortunately, we have to face with the fact to perform the audits because there is a GMP – Good Manufacturing Practices requirement. Actually our real problem is that to believe that the more we audit, the more we will comply with regulations and laws. However, GMP is talking about the a reality that audits are carried out to ensure that all our operations are guaranteed.

* Are you outsourcing your Manufacturing and / or Analysis Operations?
* Are you packing your products after bringing them from abroad in bulk?
* Do you have contracted service provider agreement with other pharmaceutical companies?
* Do you want to increase the number of countries you export to in your portfolio?
* Do you want to control and qualify the Pharmaceutical Active Ingredient (API), Excipient, Primary & Secondary Packaging Materials Manufacturers and / or Suppliers, which are the most important components for Pharmaceutical Production?
* Do you want to develop your business in other areas?
* Do you want to prepare for MHRA, FDA, PIC / S or any other authority audits and avoid any findings?
* Are you a health authority auditor who is willing to improve his auditing skill?

We do know that the majority of your answers are “Yes”. The ability to fulfill all these responsibilities completely and successfully is directly related to your performance in all the audits you experience. A good audit can take place with your GMP Lead Auditors who have mastered in GMP and Pharmaceutical Quality Management Systems. GMP inspection mechanism is the most important criterion in performance measurements and it is a golden value opportunity for the continuous development of your Pharmaceutical Quality Management System. Thanks to GMP, you prioritize the efficiency, quality and safety of your products you manufacture. However, in today’s competitive market, pharmaceutical companies are paying more attention to business success, customer-oriented approaches and improved process performances. The most critical point in the success of Pharmaceutical Quality Management Systems is GMP Audits and you are the GMP Lead Auditors who carry out these audits. While a successful Lead Auditor performs GMP-compliant audits, he must also be able to uncover areas with development opportunities, taking into account all processes of his organization.

The format of this training is to educate and train GMP Lead Auditors who can discover opportunities where there may be real performance gains while performing GMP Audit. Having auditors with both features in today’s business world will fill a very important gap in order for your organization to compete without lagging behind the market. Pharmaceutical Companies employing certified GMP Lead Auditors are your most key employee to fully prepare for both GMP Internal Audits and Customer Audits as well as Supplier and Health Authority audits. With this training, you will learn how to achieve real added value, how to improve the performance of your processes, as well as how to conduct GMP-compliant audits by observing some indispensable criteria.

After the lectures, your GMP knowledge will rise to the highest level with Scenarios, Case Studies. In addition to the training presentation, BONUS documents containing approximately hundreds of questions including GMP & GDP and Data Integrity Audit Question Lists will also be presented. The six (6) day Certified Pharmaceutical Quality Management System & GMP Lead Auditor training organized by QUALITY ACADEMIA was designed and developed by experts who worked as Managers and Lead Auditors in the Pharmaceutical Industry. Our course has a content enriched with interactive applications, scenarios work, role plays.

ADVANTAGES OF THE TRAINING

  • Corporate efficiency and effective continuous improvement
  • Achieving Internal Corporate and Quality Assurance Goals
  • Increased compliance with EU, PIC / S, TMMDA and FDA regulations
  • Improving your company’s Pharmaceutical Quality Standards and Control systems
  • Conducting a risk and process based audit with the help of effective risk management
  • Effective management of internal GMP Audits
  • Effective management of Customer, Supplier and Health Authority audits
  • Integration of your company’s Pharmaceutical Quality Management Systems
  • Continuous development of health authorities inspectors
  • An international platform opportunity where employees of company producing, marketing, storing, distributing medical pharmaceutical products in international markets can come together and network

A FEW OF THE TOPICS THAT PARTICIPANTS WILL LEARN…

  • Top Management’s perspective on GMP Audits
  • How to provide added value to the organization when conducting an audit?
  • How are pharmaceutical quality management systems implemented in your company?
  • What are the features that auditors should have?
  • How are effective and efficient audits planned, announced, performed and reported?
  • How to perform Follow-Up Audits?
  • How is a remote audit performed?
  • How to maximize the use of limited audit resources?
  • How to overcome cultural differences in inspections?
  • How are language problems overcome?
  • Pharmaceutical Quality Management System Model of FDA and ICH Q8, 9, 10, 11, 12 and others
  • How is a Pharmaceutical Active Ingredient Manufacturer / Supplier audited?
  • How is a Excipient Manufacturer / Supplier audited?
  • How is a Packaging Material Manufacturer / Supplier audited?
  • How is a Sterile Area audited?
  • How is a Quality Control Laboratory audited?
  • How is a Biotechnology Facility audited?
  • How are Computerized Systems and Data Integrity audited?
  • How are critical utilites (HVAC, Water, Gas, Steam etc.) audited?
  • How to respond to Form 482, 483?
  • How to benefit from ISO 19011 standard before, during, after audit?
  • How should the process and risk based approach be adopted in the audit?
  • How is the audit checklist developed?
  • How to focus on important risk areas?
  • How to integrate Business and Pharmaceutical Quality Management Systems?
  • How can ISO 9001 develop GMP Quality Management principles?

Our training program will last 6 days, 3 days a week.

Our Training Program will take place as follows;

Part I 16.06.2025- 17.06.2025-18.06.2025

Part II 23.06.2025- 24.06.2025-25.06.2025

Our Training will be presented as “ONLINE”

DAY 1 (16.06.2025)
08:45 – 09:00 Welcome / Meeting

09:00 – 09:15 About Training

09:15 – 09:30 Chapter 1 Quality Academia & Exemplar Global

09:30 – 10:45 Chapter 2 Quality Definitions and Quality & Cost & Safety

10:45 – 11:00 Break

11:00 – 11:45 Chapter 3 Introduction to ISO 9000 Series

11:45 – 12:30 Chapter 4 Other Quality Management System Standards

12:30 – 13:30 Lunch Break

13:30 – 14:30 Chapter 5 Quality Models

14:30 – 14:45 Break

14:45 – 15:30 Chapter 6 Quality Approaches

15:30 – 16:45 Chapter 7 What is ISO 9001?

16:45 – 17:10 End of Day Exam

17:10 End of Day 1

DAY 2 (17.06.2025)

09:00 – 09:15 Day 1 Assessment

09:15 – 10:30 Chapter 8 Pharmaceutical Quality Management Systems & GMP

10:30 – 10:45 Break

10: 45- 12:30 Chapter 8 Pharmaceutical Quality Management Systems & GMP

12:30 – 13:30 Lunch Break

13:30 – 14:45 Chapter 9 Audits – What is an Audit?

14:45 – 15:00 Break

15:00 – 16:30 Chapter 9 Audits – Why Audits?

16:30 – 17:00 Chapter 9 Audits – What is Required for an Audit?

17:00 – 17:40 End of Day Exam

17:40 End of Day 2

DAY 3 (18.06.2025)

09:00 – 09:15 Day 2 Assessment

09:15 – 10:30 Chapter 9 Audit – Roles & Responsibilities

10:30 – 10:45 Break

10:45 – 12:30 Chapter 9 Audit – Preparation & Planning

12:30 – 13:30 Lunch Break

13:30 – 14:45 Chapter 9 Auditor Selection- Building a Team

14:45 – 15:00 Break

15:00 – 16:30 Chapter 9 Audit- Documentation

16:30 – 17:00 Chapter 10 Audit Strategy (Opening-Closing Meeting, Audit Findings, CAPA, Risk-Based Audits, Audit Preparations)

(FDA, PIC / S, EMA, TGA, MHRA, WHO, TMMDA), 483 and Warning Letters

17:00 – 18:00 End of Day Exam

18:00 End of Day 3

DAY 4 (23.06.2025)

09:00 – 09:15 Day 3 Assessment

09:15 – 10:30 Chapter 11 Supplier Audits / API

10:30 – 10:45 Break

10:45 – 12:30 Chapter 12 Supplier Audits / Excipient

12:30 – 13:30 Lunch Break

13:30 – 14:45 Chapter 13 Supplier Audits / Packaging Materials

14:45 – 15:00 Break

15:00 – 16:00 Chapter 14 Computerized Systems & Data Integrity

16:00 – 17:00 Chapter 15 Logistics Service Provider

17:00 – 17:30 End of Day Exam

17:30 End of Day 4

DAY 5 (24.06.2025)

09:00 – 09:15 Day 4 Assessment

09:15 – 10:30 Chapter 16 Internal Audits, Documentation, Laboratory

10:30 – 10:45 Break

10:45 – 11:30 Chapter 17 Biopharmaceutical Facility Audit

11:30 – 12:30 Chapter 18 Validation & Equipment Qualification

12:30 – 13:30 Lunch Break

13:30 – 14:45 Chapter 18 Validation & Equipment Qualification

14:45 – 15:00 Break

15:00 – 16:30 Chapter 19 Stability

16:30 – 16:45 Chapter 20 OOS & OOT

16:45 – 17:15 End of Day Exam

17:15 End of Day 5

DAY 6 (25.06.2025)

09:00 – 09:15  Day 5 Assessment

09:15 – 10:30 Chapter 21 Utilities, Engineering, Software Suppliers, Dissolution, Cleanrooms, Environmental Monitoring

10:30 – 10:45 Break

10:45 – 12:30 Chapter 22 Disinfection, Aseptic Operations, Media Fill, Sterile Manufacturing, Sterilization, Lyophilization

12:30 – 13:30 Lunch Break

13:30 – 14:45 Chapter 22 Covid-19 and Remote Audit, Deviation, Complaint, Change Control, Manufacturing Records, Training

14:45 – 15:00 Break

15:00 – 16:30 Chapter 24 Participant Needs Controls

16:30 – 16:45 Chapter 25 Final Checks

16:45 – 18:15 Final Exam

18:15 End of Training

 

 

 

 

 

Mustafa Edik

After graduating as a Chemist from University, Mustafa Edik began his more than 25 years of career as a Laboratory Supervisor at a German Pharmaceutical Company named Bayer. Then he finished his second university degree in Biopharmaceutical Sciences BSc (Hons) in Ireland. 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 to Turkish Atomic Energy Authority as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Türkiye Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and Industries. He has prepared and presented various trainings, and workshops to more than 7.000 individuals from 100 International and Local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP, and Pharmaceutical Quality Management Systems. He took part in several International Pharmaceutical Facility Establishment projects as GMP Consultant. He set up various Quality Management Systems to Local Pharmaceutical and Medical Device Companies. While he was the Vice President of Quality and Technical Operations at Quality Academia Training & Consultancy firm, he acquired and convert it into a 100 % Turkish Company. As an only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Türkiye, he currently conducts API, Excipient, Packaging Materials Suppliers & Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, WHO regulations and guidelines.

WHICH STAFF?

• GMP Compliance
• Quality Assurance & Quality Control
• Validation & Stability

• R&D
• Auditing
• Regulatory Affairs
• IT
• Warehouse & Supply Chain
• Engineering
• Procurement

WHICH COMPANY & INSTITUTION?
• Pharmaceuticals, Medical Devices, Biotechnology Companies
• Active Pharmaceutical Ingredient Manufacturers & Suppliers
• Equipment Manufacturers & Suppliers
• Packaging Material Manufacturers & Suppliers
• Firms Offering Contractual Manufacturing & Laboratory Analysis Services
• 3rd Party Logistics Service Providers
• Software, Hardware Providers
• Companies of Calibration & Qualification Service
• Companies of Pest Control Service
• TMMDA Inspector Candidates
• TMMDA Inspectors
• Ministry of Agriculture & Forestry Auditors

To participate in the “Certified Pharmaceutical & Biotechnology GMP Lead Auditor ” training applicants should have

Minimum 3 years of experience in the relevant departments of pharmaceutical companies

Knowledge of the requirements of ICH Q8, 9, 10

A basic knowledge of the requirements of the relevant GMP, GLP, GDP legislation, and guidance for the discipline in which they will audit.

In order to participate in the training, REGISTRATION must be completed. An e-mail is sent to the participant after registration.

Tuition fees; Certificate, Training documents and Bonus are included. Certificates are delivered electronically to the participants by the Trainer / Trainers at the end of evaluation of the training. Payments (including VAT) must be made to the bank account declared in advance within the specified dates. Payment receipts should be sent to info@qualityacademia.com Registration is done in order of payment. QA reserves the right to delete the participant’s registration without notice for payments that are not made without a written justification until 15 days prior to the training date. In written cancellation notifications made 15 days before the training date, 20% of the tuition fee is refunded. No refunds are made for later cancellations, only name changes are made. The invoice to be issued is sent by courier to the address and to the notified person after the training. The completed registration is a commitment. It is the responsibility of the invoiced person or company if the participant is not present in the training hall (face to face or online trainings), which was notified on the date of training. Training announcements are made 30-90 days before training. Quality Academia reserves the right to make changes to the training date, training hall and instructor without prior notice.

Early Bird Registration

(Until 28 March 2025)

Register Now

Pre-Event Registration

(Until 30 May 2025 )

Register Now

Registration During the Event

(Late Registration)

Register Now

3500 USD / 1-3 Person

3400 USD / 4-7 Person

3300 USD / 8-12 Person

Plus VAT 20%

3600 USD / 1-3 Person

3500 USD / 4-7 Person

3400 USD / 8-12 Person

3700 USD / 1-3 Person

3600 USD / 4-7 Person

3500 USD / 8-12 Person

 

University / Government Institution / Student Discount

Those who want to benefit from the discount must first specify the University, Institution, Student e-mail address during registration.

In order to be eligible for a discount, the dates in the table above should be taken into account. The discount rate is 15% for 1 Person. The increase in the number of participants will not cause any increase in the discount.

Online training is one of the most effective learning methods and it is very important for the continuous training of Pharmaceutical, Biotechnology, Medical Device industries staff. Quality Academia Training & Consultancy offers online opportunities completely specific to its client company’s needs and expectations. On-line trainings consist of modules that client staff will access by logging in with their user name and password, and adjust the time and speed according to the working conditions. Each module is user friendly. Some of the QA’s pre-recorded online  modules are as follows; Good Manufacturing Practices, Good Laboratory Practices, Good Distribution and Storage Practices. QA also runs online live webinars on several GXP related topics such as GMP (Good Manufacturing Practices), GDP (Good Distribution practices), GQCLP (Good Quality Control Laboratory Practices), GSP (Good Storage Practices) etc.

Please get in touch with us if you have online corporate training needs at info@qualityacademia.com

Ceritificate Validity

The certificate issued at the end of the training will be valid for 3 years from the date of issue. At the end of the third year, retraining may not be taken, but it is necessary to take the relevant evaluation exam.

Exemplar Global Inc. provides personnel certification, credential management for individuals seeking further professional recognition and independent certification for training providers to enhance their course quality and outcomes. We build career pathways that support your career pathway. Our 25 years of building certification programs for our customers has provided us with the expertise to partner with you in the design, development, and delivery of a sustainable, recognized career for your profession. Our goal is to help guide your career requirements through our knowledge of what industry is seeking. At Exemplar Global, we believe that the right people with the right skills deliver the right outcomes.

https://exemplarglobal.org/

Here are some of the GMP Updates

  • APIC New Update of the ICH Q7 “How to do document”
  • APIC FQA on Data Integrity
  • APIC Quality Agreement Guideline
  • Update of the Q&A Document on Nitsosamines
  • Nitrosamine Impurities General Monographs 2034, 2619
  • USP Update on GDP
  • USP <1083> New Chapter Supplier Qualification
  • Bacterial Endotoxin Test
  • ICH Q5A (R2)
  • ICH Q9
  • ICH Q2, Q14
  • ICH Q12 Training Modules
  • ICH Q13 Continuous Manufacturing
  • ICH M10 Guideline on Bioanalytical Method Validation
  • VICH: API For Veterinary Medicinal Products
  • PIC/S
  • EU GMP Annex 1
  • Revision of the EU GMP Guide Annex 11
  • EMA’s 3 Year Work Plan
  • EMA Q&A on GDP
  • EMA’s Q&A on Annex 1
  • EMA’S Medicine Shortage Guide and Toolkit
  • EMA’s Q&A Shelf Life of Sterile Products
  • EDQM Blood Guide
  • European Council’s Update: Harmonised Standard for Medical Device Sterilization
  • FDA’s Quality Oversight
  • FDA’s The Drug Supply Chain Security Act (DSCSA)
  • Swissmedic’s Q&A on Annex 1
  • Swissmedic GMDP Database
  • MHRA’s Cooperation with Partners
  • UK Approved Bodies for Medical Devices
  • Cannabis GMP update on TGA
  • WHO’S Draft Guidance on QC Labs
  • WHO Quality Assurance of Pharmaceuticals
  • ANVISA’s ATMPs GMP Guide Approval
  • ANVISA Q&A Edition 5, on Good Manufacturing Practices (Portuguese)
  • India’s Health Ministry GMP
  • ISO 14644 Cleanroom Standards Updates
  • GAMP 5 Revision
  • Veterinary Guidelines Revisions

Details

Start:
June 16
End:
June 18
Cost:
USD3500

Organizer

Quality Academia
Phone:
+905305693441
Email:
info@qualityacademia.com
Website:
www.qualityacademia.com