In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device.

Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance.

Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.

00:03 Introduction and Guest Introduction

01:47 Understanding the Economic Operator Model

07:56 Legal Manufacturer

09:41 The Role of the Authorized Representative and PRRC

23:39 Understanding the Role and Responsibility of Authorized Representatives

26:14 The Role of Importers and Distributors

27:38 The Importance of Traceability in the Supply Chain

38:14 Terminating a Mandate with a Manufacturer

40:55 Conclusion and Easy Medical Device

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.

Easymedicaldevice.com

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.

David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards and parameters set by the EU and ISO, and he suggests various resources, including Annex one

01:01 Experiences in Clean Room

04:23 Exploring Clean Rooms

15:43 Differences Between Isolators and RABs

19:15 Different Types of Isolators

25:53 Understanding the Standards and Guidelines

28:36 How to Learn More About Clean Rooms?

30:13 Conclusion

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin here or at [email protected]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Entrepreneurial Venture: Life Science Professionals**

As the founder of Life Science Professionals, David leverages his extensive executive leadership and hands-on industry expertise to deliver tailored solutions. The firm specializes in guiding clients through the complexities of project management, engineering, and quality.

**Active Involvement in ISPE:**

Beyond his consulting work, David is deeply committed to advancing the industry through active participation in the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves in key leadership roles, including:

- Secretary for the Global Project Management COP

- Secretary for the Great Lakes Chapter

- Steering Committee Member for Digital Validation

- Steering Committee Member for the Special Interest Group on AI and Machine Learning

- Participant in Mentorship Program with Women In Pharma

**Contact Information:**

For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.

On this episode, I was joined by Douglass(Doug) Mead, Combination Products Expert and Founder of CP Pathways.

Doug presents a thorough walkthrough of drug master files (DMFs) and device master files (MAFs), their types, and their differences. Drawing on his industry experience, he explains advantages, challenges, and practical ways to handle and maintain these files in biopharma companies. Doug provides case examples, discusses trends, future prospects of DMFs and MAFs, and offers advice for companies dealing with aspects of master file content.

Markers:

01:46 Understanding Drug Master Files and Device Master Files

05:11 Doug's Experience with Master Files

07:43 Challenges and Advantages of Using Master Files

11:33 The Role of Device Master Files

12:44 Overlap Between DMFs and MAFs

31:14 The Future of Master Files

Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.

www.cppathways.com

On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen.

In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the approach towards health hazard assessments. Additionally, they delve into managing product responsibilities, the varied international reporting requirements, and the use of technology for improved efficiency.

00:54 Post-Market Safety Reporting

05:23 Challenges in Post-Market Safety Reporting

07:57 Reporting Databases

10:05 21 CFR Part 4b Guidance

11:50 Managing Product Responsibilities

19:12 Challenges in Handling Platforms

23:10 Understanding Health Hazard Assessment

25:32 International Approach to Reporting

Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

In this episode, I was joined by Jeanne Moldenhauer, a sterilization expert to discuss all things gas sterilization.

Jeanne and I explore how efficiency is determined by the seal of the container and the type of material being sterilized. Jeanne discusses its application in medical devices, the challenge of permeability, and its comparative cost-effectiveness. Jeanne delves into how the sterilization process works, safety considerations, validation, and the use of gas sterilization in combination products. Lastly, Jeanne discuss sterilization process development and the challenges that come with gas sterilization.

00:23 Deep Dive into Gas Sterilization

00:46 Applications and Limitations of Gas Sterilization

01:51 Understanding Material Permeability in Gas Sterilization

02:29 Gas Sterilization in Medical Devices

06:15 Different Types of Gases Used in Sterilization

07:41 Safety and Environmental Risks of Gas Sterilization

14:14 Understanding the Gas Sterilization Process

18:25 Safety Measures in Handling Gas Sterilization

25:39 Validation and Bioburden Considerations in Gas Sterilization

35:28 Gas Sterilization in Combination Products

Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

On this episode, I was joined by Katherine Eban, the New York Times best-selling author of "Bottle of Lies".

In this episode, Katherine dives deep into her decade-long investigation into the quality issues prevalent in generic drug manufacturing overseas. Eban highlights the need for improving transparency in the pharmaceutical industry. She shares some inspiring stories of dedicated professionals in the industry who strive to ensure patients receive quality. Eban also discusses her findings on fraudulent practices in manufacturing plants and the role of quality data in drug production. The episode sheds light on the importance of understanding the manufacturing process behind generic drugs and critical quality control issues needing urgent attention.

Time-Stamps:

02:12 The Start of the Investigation into Generic Drug Quality

08:59 The Impact of Quality Issues on Global Health

12:54 Understanding the FDA's Role in Drug Quality Control

16:55 The Struggle to Maintain Quality in the Pharmaceutical Industry

18:39 The Ranbaxy Story

27:45 Peter Baker

30:19 Quality Stories

33:27 Conclusion and Final Thoughts

Link to Katherine's Book: Bottle of Lies: The Inside Story of the Generic Drug Boom, is a New York Times bestseller and one of the New York Times’ 100 Notable Books of 2019.

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.

Jeanne talks through the different methods of irradiation like gamma, beta, microwave, x-ray, and ebeam, their respective pros and cons, as well as their environmental impacts. Jeanne also delves into the practical considerations associated with this sterilization method.

This includes important factors like product density, cycle development, dosimeters, sterilization and the bioburden. The episode ends with a look at the regulatory approval process, addressing the timeline for validating an irradiation sterilization cycle.

00:22 Understanding Irradiation Sterilization

00:34 Differences between Autoclaving and Irradiation

04:22 The Impact of Product Density on Irradiation

05:09 The Role of Dose in Irradiation Sterilization

06:21 E-beam Sterilization

08:52 Impact of Gamma Sterilization on Different Materials

22:07 The Role of Bioburden in Irradiation Sterilization

30:19 Dosimetric Release

37:31 Gamma Irradiation for Combination Products

41:59 The Process of Validating an Irradiation Sterilization Cycle

Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

On this episode, I was joined by Ira Mann, President at IQ Referrals. Ira and I discuss:

- Pharma/MedTech Market and Positioning for Success

- Why people leave good companies

- Finding Motivation in Pharma/Quality

- Remote Work, Insourcing, On-Shoring in US Manufacturing

Ira Mann is President, IQ Referrals. With more than 20 years in the recruiting industry, Ira is an expert at placing top professionals in the Quality, Validation, Regulatory Affairs, Cold Chain, Environmental Monitoring and Sterilization specialties, and is strategically aligned with experts conducting searches in Engineering, R&D and Manufacturing Management.

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.

 Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

On this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals. 

The books are:

I find that I read a lot more in December so wanted to give you all some recommendations this Thanksgiving week. Happy Thanksgiving!