Speaker Profile

Courtland
Courtland Imel
CEO , Ceutical Laboratories,

Courtland Imel is CEO of Ceutical Laboratories. Courtland has provided training to FDA, Health Canada, and state regulatory authorities. Courtland has spoken at AFDO, AFDOSS, MCAFDO, ASQ, SCC, and Bio. Courtland has 35 years of experience in the industry. Courtland is an SME for several organizations and law firms. Courtland worked for M&M Mars, Allergan, ILEX Oncology, Aronex Pharmaceuticals, Mills Biopharmaceuticals, International Isotopes, Avail Medical Products, Carrington Laboratories, and Ceutical Laboratories, Inc. Courtland has assisted in the submissions of 510Ks, PMAs, IND’s, NDAs, ANDAs, IDEs, and more.

Ceutical Labs provides many services including product development, formulation development, analytical testing (chemistry, microbiology, and physical), regulatory submissions, electronic submissions, consulting, training, quality systems, and more.

Upcoming Webinars Recorded Webinars
  • 6
  • February
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

Good Documentation Practices

The presentation will include: where GDP can be found in the CFR, We will discuss definitions of documentation, raw data, record keeping, and some do's and don't's.

Courtland Imel Courtland Imel | Duration:60 Minutes | Price: $150.00 | View Details
  • 3
  • March
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

FDA Audit - Responsibilities of the Auditor and Responsibilities of the firm

The presentation will include the types of audits that could occur. What happens when you receive an audit off shore vs. within the US. How do you prepare for these audits? What must be done prior to the audit? What happens during the audit? What happens after the audit? How do you respond? What happens differently if a consultant is involved?

Courtland Imel Courtland Imel | Duration:60 Minutes | Price: $150.00 | View Details
  • 19
  • March
  • 2020
  • Thursday
10:00 AM PST | 01:00 PM EST

Pharmaceutical Supply Chain Management

The presentation will include recent comments by MCA and FDA on the use of criminal supply chains and how to spot them.

Courtland Imel Courtland Imel | Duration:60 Minutes | Price: $150.00 | View Details
  • 7
  • April
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

Change Management System

The presentation will focus on FDA responses to failures in Change Management. The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Courtland Imel Courtland Imel | Duration:60 Minutes | Price: $150.00 | View Details
Courtland Imel

Good Documentation Practices

The presentation will include: where GDP can be found in the CFR, We will discuss definitions of documentation, raw data, record keeping, and some do's and don't's.

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Courtland Imel

FDA Audit - Responsibilities of the Auditor and Responsibilities of the firm

The presentation will include the types of audits that could occur. What happens when you receive an audit off shore vs. within the US. How do you prepare for these audits? What must be done prior to the audit? What happens during the audit? What happens after the audit? How do you respond? What happens differently if a consultant is involved?

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Courtland Imel

Pharmaceutical Supply Chain Management

The presentation will include recent comments by MCA and FDA on the use of criminal supply chains and how to spot them.

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Courtland Imel

Change Management System

The presentation will focus on FDA responses to failures in Change Management. The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Courtland Imel

Good Documentation Practices

The presentation will include: where GDP can be found in the CFR, We will discuss definitions of documentation, raw data, record keeping, and some do's and don't's.

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Courtland Imel

FDA Audit - Responsibilities of the Auditor and Responsibilities of the firm

The presentation will include the types of audits that could occur. What happens when you receive an audit off shore vs. within the US. How do you prepare for these audits? What must be done prior to the audit? What happens during the audit? What happens after the audit? How do you respond? What happens differently if a consultant is involved?

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Courtland Imel

Pharmaceutical Supply Chain Management

The presentation will include recent comments by MCA and FDA on the use of criminal supply chains and how to spot them.

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Courtland Imel

Change Management System

The presentation will focus on FDA responses to failures in Change Management. The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

Speaker: Courtland Imel | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details