Best Moldenhauer Podcasts (2024)

1
'The River of God' Abi Moldenhauer 52:14

6h ago52:14

52:14

Abi looks at how when we take our love for God seriously, it allows His power to flow, to change our hearts and reach those around us.

1
131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer 42:53

15d ago42:53

42:53

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:- Assessing Drugs, Devices, and Combination Products for Sterility Methods- Regulatory Frameworks and EMA's Decision Tree (Link)- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure s…

1
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell 22:26

2h ago22:26

22:26

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.Devon discusses: 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a P…

1
Joy overlaps our pain and overcomes our sorrow 20:16

2d ago20:16

20:16

The sermon for the Fourth Sunday of Easter based on John 16:16-22By Pastor Caleb Bassett

1
132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner 31:11

8d ago31:11

31:11

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: 00:56 Evolution of Industry Standards 02:00 The Impact of Standards on Medical Device Development 02:10 Standards and Regulatory Challenges 02:42 Standards in Medical Devices and Emerging Technologies 13:19 The Auditing…

1
Know Yourself as Jesus Knows You 15:49

4d ago15:49

15:49

A sermon based on John 10:11-16 Our Redeemer Lutheran Madison April 14, 2024By Pastor Philip Moldenhauer

1
'The Hidden Years' Darren Johnson 35:27

4d ago35:27

35:27

Darren continues our talk series 'The Apostle Paul: A Life Transformed', looking at how Paul faithfully proclaimed the gospel in spite of many hardships and setbacks.

1
'A Changed Life' Johnmark Horton 40:23

14d ago40:23

40:23

Johnmark begins a new series of talks called 'Paul: A Life Transformed', looking at how Paul sets us an example of a life of following Jesus through forgiveness, faith and focus.

1
Testimony connects us to the touch of Thomas 23:19

19d ago23:19

23:19

Sermon for the seconday Sunday of Easter based on John 20:19-31By Pastor Caleb Bassett

1
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder 32:25

15d ago32:25

32:25

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies 02:19 UDI Regulations 05:18 Understanding the FDA's Approach to QMSR and Compliance 18:02 The FDA's Inspection Techniques and the Future of QMSR 31:55 Where to Find Aaron and Closing Thoug…

1
I believe in the resurrection of the body 18:10

19d ago18:10

18:10

Sermon for Easter Sunday 3-31-2024 based on Mark 16:1-8By Pastor Phil Moldenhauer

1
'The Four Gardens' Darren Johnson 33:15

26d ago33:15

33:15

For Easter Sunday, Darren looks at how Jesus has made a way for us to receive forgiveness and become a part of God's family.

1
'The Power of the Cross' Dan Curtis 10:21

20d ago10:21

10:21

For Good Friday, Dan looks at how we can face all of life's challenges through Jesus who made the way clear for us to come to God.

1
The body of Christ gathers around the body of Christ 26:46

28d ago26:46

26:46

A sermon based on 1 Corinthians 11:23-32 Maundy Thursday March 28, 2024 Our Redeemer Lutheran Church MadisonBy Pastor Philip Moldenhauer

1
129 - Reliability for Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens 32:59

28d ago32:59

32:59

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. A…

1
'Serving and being served' Jacky Johnson 35:11

1M ago35:11

35:11

Jacky continues our talk series 'Family on Mission', looking at how giving Jesus all of our worship is a costly process.

1
Prophecy accomplishes more than prediction 16:21

1M ago16:21

16:21

Sermon based on John 12:12-19By Pastor Philip Moldenhauer

1
128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture 52:32

29d ago52:32

52:32

On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story 07:25 Understanding the Impact of QMSR on Industry 16:24 The FDA's Approach to Inspections and Compliance 27:45 The Shift Towards Quality Culture in F…

1
Leading with Grit: Zero Trust in the Finance Sector with Darin Hurd, CISO at Guaranteed Rate 42:17

1M ago42:17

42:17

Darin Hurd, EVP and CISO at Guaranteed Rate, explains the value of zero trust security in the financial sector. Lenders cannot control the federal funds interest rate or the state of the economy, which can change rapidly. However, they must respond and adapt to these variables and others while ensuring their infrastructure remains secure. Darin exp…

1
Time bends around Christ 19:04

1M ago19:04

19:04

The sermon for the fifth week in Lent based on John 8:46-59By Pastor Philip Moldenhauer

1
'Because we are loved by God' Darren Johnson 42:00

1M ago42:00

42:00

Darren continues our talk series 'Family on Mission', looking at how through the Father, Son and Holy Spirit we are called to demonstrate God's love in community, in serving and in telling others about Jesus.

1
You would have no power if it were not given to you 18:41

1M ago18:41

18:41

A sermon based on John 19:8-11 Our Redeemer Lutheran Madison March 13, 2024By Pastor Caleb Bassett

1
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal 48:25

1M ago48:25

48:25

On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the seco…

1
'Hospitality' Sarah Robinson 36:33

2M ago36:33

36:33

Sarah continues our talk series 'Family on Mission', looking at how we are called to make space for others, serving and allowing them to serve us.

1
In giving, we receive 19:39

2M ago19:39

19:39

A sermon based on John 6:1-15 Our Redeemer Lutheran Madison March 10, 2024By Pastor Philip Moldenhauer

1
I came to testify to the truth 13:50

2M ago13:50

13:50

A sermon based on John 18:37-38 Our Redeemer Lutheran Madison March 6, 2024By Pastor Jon Bauer

1
126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd 35:54

1M ago35:54

35:54

On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Challenges in Deep Brain Stimulation 08:55 The Impact of working with Andy Grove 10:42 The Struggle with Parkinson's Disease 13:20 The Speed of Product Deve…

1
'The Power of Forgiveness' Jacky Johnson 35:31

2M ago35:31

35:31

Jacky continues our talk series 'Family on Mission', looking at how since we are saved through God's mercy rather than justice we are called to live in forgiveness.

1
Align yourself on the winning side of the war 20:10

2M ago20:10

20:10

Sermon for the third Sunday in Lent based on Luke 11:14-28By Pastor Caleb Bassett

1
Put your sword away 11:32

2M ago11:32

11:32

A sermon based on Matthew 26:52-54 Our Redeemer Lutheran Madison February 28, 2024By Vicar Borgwardt

1
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh 42:04

2M ago42:04

42:04

On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction 05:09 Initial Reactions to the idea of the QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR …

1
What if God asks the impossible? 18:54

2M ago18:54

18:54

Sermon based on Matthew 15:21 - 28By Pastor Philip Moldenhauer

1
'Four Phases and Five Spaces' Darren Johnson 38:02

2M ago38:02

38:02

Darren continues our talk series 'Family on Mission', looking at how Jesus led the disciples in different ways in different phases of their journey with Him.

1
My kingdom is not of this world 11:55

2M ago11:55

11:55

A sermon based on John 18:33-36 Our Redeemer Lutheran Madison February 21, 2024By Pastor Philip Moldenhauer

1
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson 31:01

2M ago31:01

31:01

On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out…

1
'Jesus the disciple maker who makes disciple making disciples' Darren Johnson 35:42

2M ago35:42

35:42

Darren continues our talk series 'Family on Mission', looking at how Jesus is the Way, Truth and Life, and we are called to live as He did, knowing God and leading others to Him.

1
Jesus exposes the empty claims of the devil 14:20

2M ago14:20

14:20

Sermon for Invocavit based on Matthew 4:1-11

1
Confession brings a welcome end to deception 22:58

2M ago22:58

22:58

A sermon based on 1 John 1:5-9 Ash Wednesday at Our Redeemer Lutheran Madison February 14, 2024By Pastor Caleb Bassett

1
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker 45:15

2M ago45:15

45:15

On this episode, I was joined by Peter Baker, President @ Live Oak QA. The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical…

1
Leading with empathy and transparency: Brent Deterding, CISO of Afni 47:17

2M ago47:17

47:17

Brent Deterding, CISO of Afni, knows focusing on empathy yields benefits for his personal, and professional life. Whether raising foster children, meeting with vendors, or analyzing cyber attacks, his policy of treating others with dignity opens new doors and creates opportunities. Learn how being transparent in conversations helps him avoid costly…

1
'Hunger and Thirst' Sarah Robinson 35:41

2M ago35:41

35:41

Sarah continues our talk series 'Family on Mission', looking at how the Holy Spirit is at work throughout the Bible and empowers anyone who asks.

1
The seeing faith of a blind beggar 19:11

2M ago19:11

19:11

A sermon based on Luke 18:31-43 Our Redeemer Lutheran Madison February 11, 2024By Pastor Caleb Bassett

1
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries 35:59

3M ago35:59

35:59

On this episode, I was joined by Jim Fries, CEO of Rx360. On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship buildin…

1
The hidden power of the Word 21:26

3M ago21:26

21:26

Sermon for Sexagesima service February 4, 2024 based on Luke 8:4-15.By Pastor Philip Moldenhauer

1
'The Wise and Foolish Builders' Johnmark Horton 37:48

3M ago37:48

37:48

Johnmark continues our talk series 'Family on Mission', looking at how putting our faith into action and applying the truths of the Bible brings about a changed life.

1
121 - Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi 33:26

3M ago33:26

33:26

On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member. Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pharma industry. Sayed provides advice for people considering their career paths and emphasizes the importance of gaining expertise in a particular area …

1
Justice is outweighed by grace 22:14

3M ago22:14

22:14

Sermon based upon Matthew 20:1 -16By Pastor Philip Moldenhauer

1
'The truth sets us free' Jacky Johnson 39:10

3M ago39:10

39:10

Jacky continues our talk series 'Family on Mission', looking at how knowing who God is brings inner transformation.

1
120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi 43:06

3M ago43:06

43:06

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 perso…

1
'Make Room for the Holy Spirit' Darren Johnson 38:40

3M ago38:40

38:40

Darren continues our talk series 'Family on Mission', looking at how having a lifestyle of spending time with God allows Him to move in our circumstances.

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Moldenhauer Podcasts

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