Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards
Are FDA Approval Complexities and Multi-State IND Compliance Challenges Creating Critical Bottlenecks in Your Pipeline?
Instructor :
John E Lincoln
Webinar ID:
12550
Date: APR 11, 2025 (FRI)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🛡️ The Compliance and Approval Accelerator Bundle (Pack of 3 Courses)
“Navigate FDA Approvals with Confidence and Speed!”
3 Courses Included:
-
- Accelerate Your FDA 510(k) and PMA Submissions: A 3-Hour Virtual Seminar for Faster Approval, duration is 3 Hrs., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards for 2025 Success, duration is 60 Mins., find out more details here
- Inside the Auditor’s Mind: Master FDA Audit Preparation with Expert Insights, duration is 90 Mins., find out more details here
Why Pack These Together?
These courses cover every stage of regulatory approval: submissions, drug manufacturing standards, and audit preparation. They’re ideal for professionals responsible for ensuring fast, efficient, and compliant regulatory pathways.
Why Buy the Pack?
-
- Comprehensive Approach: Master the regulatory process from submission to audits.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🛡️ The Compliance and Approval Accelerator Bundle (Pack of 3 Courses)
“Navigate FDA Approvals with Confidence and Speed!”
3 Courses Included:
-
- Accelerate Your FDA 510(k) and PMA Submissions: A 3-Hour Virtual Seminar for Faster Approval, duration is 3 Hrs., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards for 2025 Success, duration is 60 Mins., find out more details here
- Inside the Auditor’s Mind: Master FDA Audit Preparation with Expert Insights, duration is 90 Mins., find out more details here
Why Pack These Together?
These courses cover every stage of regulatory approval: submissions, drug manufacturing standards, and audit preparation. They’re ideal for professionals responsible for ensuring fast, efficient, and compliant regulatory pathways.
Why Buy the Pack?
-
- Comprehensive Approach: Master the regulatory process from submission to audits.
- Massive Savings: More affordable than purchasing each webinar separately.
- Target Professionals: Regulatory Affairs Managers, Quality Assurance (QA) Officers, and Compliance Specialists.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
Buy All 3 Courses at a 35% discount HERE
What will you learn
-
- Overview Of FDA’s Role In Drug Regulations And Compliance
- Step-By-Step Guidance On Navigating The NDA Approval Process
- Insights Into IND Applications And Multi-State Clinical Trial Exemptions
- Comprehensive Understanding Of Drug cGMP Standards And Requirements
- Strategies To Address Regulatory Hurdles And Compliance Risks Effectively
- Post-Market Monitoring, Reporting, And Safety Compliance For ….
-
- Overview Of FDA’s Role In Drug Regulations And Compliance
- Step-By-Step Guidance On Navigating The NDA Approval Process
- Insights Into IND Applications And Multi-State Clinical Trial Exemptions
- Comprehensive Understanding Of Drug cGMP Standards And Requirements
- Strategies To Address Regulatory Hurdles And Compliance Risks Effectively
- Post-Market Monitoring, Reporting, And Safety Compliance For FDA Approval
- Key Data Submission Protocols To Streamline Approvals And Avoid Delays
Course Description
With Q2 of 2025 approaching, now is the perfect time to refine your FDA approval strategy and stay ahead in the evolving regulatory landscape.
As pharmaceutical companies push for faster market entry, mastering New Drug Applications (NDAs), Investigational New Drugs (INDs), and Current Good Manufacturing Practices (cGMPs) is more crucial than ever.
This expert-led, 60-minute session is designed for regulatory affairs professionals, drug developers, and compliance specialists looking to streamline approvals, avoid costly delays, and ensure manufacturing excellence.
What You’ll Learn:
-
- Master NDAs
-
- Get a clear roadmap for New Drug Applications, ensuring compliance and efficiency in submission and approval processes.
-
- Master NDAs
-
- Navigate INDs
-
- Understand the Investigational New Drug (IND) process, including exemptions, multi-state clinical trial regulations, and submission best practices.
-
- Navigate INDs
-
- Achieve cGMP Compliance
-
- Break down 21 CFR 210/211 requirements and implement FDA-compliant manufacturing practices to avoid regulatory pitfalls.
-
- Achieve cGMP Compliance
As mid-year regulatory deadlines approach, missing critical compliance steps could mean delays and lost opportunities. This session equips you with up-to-date strategies to navigate FDA pathways efficiently and bring your product to market faster.
April is the time to act—get ahead and secure your FDA approval success!
Join Now!
With Q2 of 2025 approaching, now is the perfect time to refine your FDA approval strategy and stay ahead in the evolving regulatory landscape.
As pharmaceutical companies push for faster market entry, mastering New Drug Applications (NDAs), Investigational New Drugs (INDs), and Current Good Manufacturing Practices (cGMPs) is more crucial than ever.
This expert-led, 60-minute session is designed for regulatory affairs professionals, drug developers, and compliance specialists looking to streamline approvals, avoid costly delays, and ensure manufacturing excellence.
What You’ll Learn:
-
- Master NDAs
-
- Get a clear roadmap for New Drug Applications, ensuring compliance and efficiency in submission and approval processes.
-
- Master NDAs
-
- Navigate INDs
-
- Understand the Investigational New Drug (IND) process, including exemptions, multi-state clinical trial regulations, and submission best practices.
-
- Navigate INDs
-
- Achieve cGMP Compliance
-
- Break down 21 CFR 210/211 requirements and implement FDA-compliant manufacturing practices to avoid regulatory pitfalls.
-
- Achieve cGMP Compliance
As mid-year regulatory deadlines approach, missing critical compliance steps could mean delays and lost opportunities. This session equips you with up-to-date strategies to navigate FDA pathways efficiently and bring your product to market faster.
April is the time to act—get ahead and secure your FDA approval success!
Join Now!
Why you should attend
With FDA regulations tightening in 2025, even minor errors in NDAs, INDs, or cGMP compliance can lead to costly delays, rejections, or extended approval timelines.
Staying informed and proactive is essential to avoid regulatory setbacks and keep your drug development process on track.
Key Benefits of Attending:
-
- Stay Ahead of Regulatory Changes
-
- Gain clarity on the latest FDA expectations and submission requirements to avoid compliance pitfalls.
-
- Stay Ahead of Regulatory Changes
-
- Reduce Approval Delays & Rejections
-
- Learn how to spot and fix submission errors before they lead to setbacks.
-
- Reduce Approval Delays & Rejections
-
- Enhance cGMP Compliance
-
- Ensure your manufacturing processes align with FDA’s evolving quality and safety standards.
-
- Enhance cGMP Compliance
-
- Cut Costs & Accelerate Market Entry
-
- Implement proven strategies to streamline approvals and reduce inefficiencies in your regulatory pathway.
-
- Cut Costs & Accelerate Market Entry
-
- Advance Your Career
-
- Strengthen your expertise in regulatory affairs and compliance, making you an invaluable asset to your team.
-
- Advance Your Career
Don’t let regulatory missteps slow down your success.
This training gives you the knowledge and tools to confidently navigate FDA approvals and bring your product to market faster.
Secure Your Spot Today!
With FDA regulations tightening in 2025, even minor errors in NDAs, INDs, or cGMP compliance can lead to costly delays, rejections, or extended approval timelines.
Staying informed and proactive is essential to avoid regulatory setbacks and keep your drug development process on track.
Key Benefits of Attending:
-
- Stay Ahead of Regulatory Changes
-
- Gain clarity on the latest FDA expectations and submission requirements to avoid compliance pitfalls.
-
- Stay Ahead of Regulatory Changes
-
- Reduce Approval Delays & Rejections
-
- Learn how to spot and fix submission errors before they lead to setbacks.
-
- Reduce Approval Delays & Rejections
-
- Enhance cGMP Compliance
-
- Ensure your manufacturing processes align with FDA’s evolving quality and safety standards.
-
- Enhance cGMP Compliance
-
- Cut Costs & Accelerate Market Entry
-
- Implement proven strategies to streamline approvals and reduce inefficiencies in your regulatory pathway.
-
- Cut Costs & Accelerate Market Entry
-
- Advance Your Career
-
- Strengthen your expertise in regulatory affairs and compliance, making you an invaluable asset to your team.
-
- Advance Your Career
Don’t let regulatory missteps slow down your success.
This training gives you the knowledge and tools to confidently navigate FDA approvals and bring your product to market faster.
Secure Your Spot Today!
Areas Covered
1. Understanding Drug Regulations & FDA’s Role
-
- Overview of the FDA’s regulatory authority over new drug approvals
- Key legal frameworks and compliance requirements for pharmaceuticals
2. Navigating the NDA (New Drug Application) Process
-
- Step-by-step guidance on preparing and submitting an NDA
- Essential data requirements for approval, including clinical and non-clinical studies
- Understanding the FDA’s evaluation criteria and how to address common concerns
3. Mastering the IND (Investigational New Drug) Process
-
- Key elements of the IND application process and submission best practices
- IND exemptions for transporting investigational drugs across state lines
- Enabling multi-state clinical trials with proper regulatory compliance
4. Preparing for Production with Drug cGMPs
-
- Overview of 21 CFR 210/211 regulations for pharmaceutical manufacturing
- Ensuring quality control, documentation, and process validation
- Common pitfalls in cGMP compliance and how to avoid them
5. Addressing Key Areas of Concern
-
- Identifying regulatory hurdles and common challenges in NDA and IND processes
- Managing data integrity, submission errors, and compliance risks
- Strategies to streamline approvals and reduce delays
6. Understanding Post-Market Requirements
-
- FDA’s post-market monitoring and reporting obligations
- Ensuring ongoing product safety, compliance, and regulatory adherence
- Handling recalls, safety updates, and periodic reporting
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
1. Understanding Drug Regulations & FDA’s Role
-
- Overview of the FDA’s regulatory authority over new drug approvals
- Key legal frameworks and compliance requirements for pharmaceuticals
2. Navigating the NDA (New Drug Application) Process
-
- Step-by-step guidance on preparing and submitting an NDA
- Essential data requirements for approval, including clinical and non-clinical studies
- Understanding the FDA’s evaluation criteria and how to address common concerns
3. Mastering the IND (Investigational New Drug) Process
-
- Key elements of the IND application process and submission best practices
- IND exemptions for transporting investigational drugs across state lines
- Enabling multi-state clinical trials with proper regulatory compliance
4. Preparing for Production with Drug cGMPs
-
- Overview of 21 CFR 210/211 regulations for pharmaceutical manufacturing
- Ensuring quality control, documentation, and process validation
- Common pitfalls in cGMP compliance and how to avoid them
5. Addressing Key Areas of Concern
-
- Identifying regulatory hurdles and common challenges in NDA and IND processes
- Managing data integrity, submission errors, and compliance risks
- Strategies to streamline approvals and reduce delays
6. Understanding Post-Market Requirements
-
- FDA’s post-market monitoring and reporting obligations
- Ensuring ongoing product safety, compliance, and regulatory adherence
- Handling recalls, safety updates, and periodic reporting
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
-
- Regulatory Affairs Specialists Seeking to Master FDA Approval Processes
- Drug Development Managers Focused on Efficiently Advancing Products to Market
- Quality Assurance Professionals Committed to Upholding Drug cGMP Standards
- Clinical Research Coordinators Overseeing Multi-State Clinical Trials
- Pharmaceutical Manufacturing Leaders Ensuring Compliance with cGMP Regulations
- Project Managers Navigating the NDA and IND Submission Journey
- Compliance Officers Aiming to Avoid FDA Regulatory Setbacks
- Training Directors Developing Regulatory Knowledge Across Teams
- R&D Scientists Focused on Meeting Clinical and Regulatory Milestones
Everybody benefits from watching this. Even better when done as a group!
-
- Regulatory Affairs Specialists Seeking to Master FDA Approval Processes
- Drug Development Managers Focused on Efficiently Advancing Products to Market
- Quality Assurance Professionals Committed to Upholding Drug cGMP Standards
- Clinical Research Coordinators Overseeing Multi-State Clinical Trials
- Pharmaceutical Manufacturing Leaders Ensuring Compliance with cGMP Regulations
- Project Managers Navigating the NDA and IND Submission Journey
- Compliance Officers Aiming to Avoid FDA Regulatory Setbacks
- Training Directors Developing Regulatory Knowledge Across Teams
- R&D Scientists Focused on Meeting Clinical and Regulatory Milestones
Instructor Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
