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: DEC 04, 2024 (WED)
Start Time: 10 AM PT - 11 AM PT
Duration: 1 Hr.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🔍 Quality & Safety Assurance Master Pack (Pack of 3)
“Strengthen Quality and Risk Management for Safe Pharmaceutical Products”
3 Courses Included:
-
- Quality Risk Management: An In-Depth Guide to ICH Q9 (R1) for Safe and Effective Pharmaceutical Products, duration 90 Mins., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards, duration 60 Mins., find out more details here
- Quality Management 101: Optimizing Enterprise Maintenance with ISO Standards, duration 60 Mins., find out more details here
Why This Pack?
This bundle equips professionals with critical knowledge in quality assurance and risk management, from new drug applications to overarching quality management systems (QMS). It’s ideal for professionals dedicated to maintaining high standards in product safety and regulatory alignment.
Target Audience: Quality Assurance Managers, Regulatory Affairs Specialists, Pharmaceutical Production Managers
Why Buy the Pack?
-
- End-to-End Quality Management: Gain in-depth expertise from drug applications to quality systems management.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🔍 Quality & Safety Assurance Master Pack (Pack of 3)
“Strengthen Quality and Risk Management for Safe Pharmaceutical Products”
3 Courses Included:
-
- Quality Risk Management: An In-Depth Guide to ICH Q9 (R1) for Safe and Effective Pharmaceutical Products, duration 90 Mins., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards, duration 60 Mins., find out more details here
- Quality Management 101: Optimizing Enterprise Maintenance with ISO Standards, duration 60 Mins., find out more details here
Why This Pack?
This bundle equips professionals with critical knowledge in quality assurance and risk management, from new drug applications to overarching quality management systems (QMS). It’s ideal for professionals dedicated to maintaining high standards in product safety and regulatory alignment.
Target Audience: Quality Assurance Managers, Regulatory Affairs Specialists, Pharmaceutical Production Managers
Why Buy the Pack?
-
- End-to-End Quality Management: Gain in-depth expertise from drug applications to quality systems management.
- Safety First: Prioritize product safety and compliance with robust quality frameworks.
- Optimal Value: Comprehensive quality assurance guidance at a lower cost than individual purchases.
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
-
- Understand FDA’s Role In Regulating New Drugs In The U.S.
- Learn Key Steps In The NDA Submission And Approval Process.
- Master The IND Process For Multi-State Clinical Trials.
- Prepare For Production With Drug cGMP Compliance Standards.
- Identify And Manage Challenges In NDA And IND Processes.
- Understand Post-Market Compliance And ….
-
- Understand FDA’s Role In Regulating New Drugs In The U.S.
- Learn Key Steps In The NDA Submission And Approval Process.
- Master The IND Process For Multi-State Clinical Trials.
- Prepare For Production With Drug cGMP Compliance Standards.
- Identify And Manage Challenges In NDA And IND Processes.
- Understand Post-Market Compliance And Ongoing FDA Requirements.
- Gain Practical Insights For Regulatory And Quality Assurance Success.
Course Description
Navigate the complex landscape of FDA drug approval with this essential training on New Drug Applications (NDAs), Investigational New Drugs (INDs), and Drug Current Good Manufacturing Practices (cGMPs).
This course breaks down the regulatory path required to bring new pharmaceuticals to market in the U.S., making it an invaluable resource for professionals in drug development, regulatory affairs, and compliance.
What You’ll Learn:
-
- The NDA Process: Discover how the New Drug Application (NDA) serves as the primary vehicle for proposing new drugs to the FDA. Understand what it takes to compile and submit the data necessary to secure approval for U.S. commercialization.
- Investigational New Drugs (INDs): Learn about the IND application and how it allows drug sponsors to legally transport and distribute investigational drugs across state lines for clinical trials. We’ll cover the exemption process and key legal requirements, ensuring you understand how INDs support drug development.
- Ensuring cGMP Compliance: Familiarize yourself with the Drug cGMP regulations (21 CFR 210/211), essential for manufacturing safe, high-quality drugs that meet FDA standards.
Key Benefits:
-
- Clear, step-by-step guidance on meeting FDA regulatory requirements from initial investigation to final market approval
- Insight into the data requirements for NDAs and INDs, helping you streamline the approval process and avoid setbacks
- Practical knowledge of cGMP standards to ensure your drug manufacturing practices align with FDA expectations and regulations
This course provides a concise, 60-minute overview of critical FDA pathways and compliance standards, empowering you with the knowledge needed to move drugs from development to market with confidence and precision.
Enroll Now!
Navigate the complex landscape of FDA drug approval with this essential training on New Drug Applications (NDAs), Investigational New Drugs (INDs), and Drug Current Good Manufacturing Practices (cGMPs).
This course breaks down the regulatory path required to bring new pharmaceuticals to market in the U.S., making it an invaluable resource for professionals in drug development, regulatory affairs, and compliance.
What You’ll Learn:
-
- The NDA Process: Discover how the New Drug Application (NDA) serves as the primary vehicle for proposing new drugs to the FDA. Understand what it takes to compile and submit the data necessary to secure approval for U.S. commercialization.
- Investigational New Drugs (INDs): Learn about the IND application and how it allows drug sponsors to legally transport and distribute investigational drugs across state lines for clinical trials. We’ll cover the exemption process and key legal requirements, ensuring you understand how INDs support drug development.
- Ensuring cGMP Compliance: Familiarize yourself with the Drug cGMP regulations (21 CFR 210/211), essential for manufacturing safe, high-quality drugs that meet FDA standards.
Key Benefits:
-
- Clear, step-by-step guidance on meeting FDA regulatory requirements from initial investigation to final market approval
- Insight into the data requirements for NDAs and INDs, helping you streamline the approval process and avoid setbacks
- Practical knowledge of cGMP standards to ensure your drug manufacturing practices align with FDA expectations and regulations
This course provides a concise, 60-minute overview of critical FDA pathways and compliance standards, empowering you with the knowledge needed to move drugs from development to market with confidence and precision.
Enroll Now!
Why you should attend
In an industry where FDA approval processes and regulatory compliance are critical, staying updated on New Drug Applications (NDAs), Investigational New Drugs (INDs), and Drug Current Good Manufacturing Practices (cGMPs) is essential for success.
This training will equip you with the knowledge and tools to navigate these complex regulations, ensuring your drug products meet U.S. standards and gain timely FDA approval.
Here’s why you can’t afford to miss this course:
-
- Master Regulatory Compliance: Understand the latest U.S. Federal laws governing NDAs and INDs to ensure your product meets all necessary FDA requirements before distribution, helping you avoid costly delays or compliance issues.
- Navigate IND Exemptions with Confidence: Learn the ins and outs of IND exemptions, which allow investigational drugs to cross state lines for clinical trials. This knowledge is critical for sponsors aiming to conduct multi-state trials and gather essential clinical data.
- Ensure cGMP Compliance for Manufacturing: Gain insight into the key requirements of Pharmaceutical cGMPs (21 CFR 210/211), including control, testing, and quality assurance (OQ/QA) protocols necessary for manufacturing drugs intended for the U.S. market, no matter where they’re produced.
- Stay Ahead in Your Career: With increasing scrutiny on drug safety and manufacturing standards, mastering these FDA regulatory pathways will enhance your expertise, improve your team’s efficiency, and position you as a knowledgeable leader in regulatory compliance.
- Practical, Actionable Takeaways: Walk away with actionable steps and strategies to streamline your approval process, reduce time-to-market, and uphold the highest standards of drug quality and safety.
This training is essential for professionals in drug development, regulatory affairs, and quality control who are committed to staying compliant and competitive in the evolving pharmaceutical landscape.
Join Now!
In an industry where FDA approval processes and regulatory compliance are critical, staying updated on New Drug Applications (NDAs), Investigational New Drugs (INDs), and Drug Current Good Manufacturing Practices (cGMPs) is essential for success.
This training will equip you with the knowledge and tools to navigate these complex regulations, ensuring your drug products meet U.S. standards and gain timely FDA approval.
Here’s why you can’t afford to miss this course:
-
- Master Regulatory Compliance: Understand the latest U.S. Federal laws governing NDAs and INDs to ensure your product meets all necessary FDA requirements before distribution, helping you avoid costly delays or compliance issues.
- Navigate IND Exemptions with Confidence: Learn the ins and outs of IND exemptions, which allow investigational drugs to cross state lines for clinical trials. This knowledge is critical for sponsors aiming to conduct multi-state trials and gather essential clinical data.
- Ensure cGMP Compliance for Manufacturing: Gain insight into the key requirements of Pharmaceutical cGMPs (21 CFR 210/211), including control, testing, and quality assurance (OQ/QA) protocols necessary for manufacturing drugs intended for the U.S. market, no matter where they’re produced.
- Stay Ahead in Your Career: With increasing scrutiny on drug safety and manufacturing standards, mastering these FDA regulatory pathways will enhance your expertise, improve your team’s efficiency, and position you as a knowledgeable leader in regulatory compliance.
- Practical, Actionable Takeaways: Walk away with actionable steps and strategies to streamline your approval process, reduce time-to-market, and uphold the highest standards of drug quality and safety.
This training is essential for professionals in drug development, regulatory affairs, and quality control who are committed to staying compliant and competitive in the evolving pharmaceutical landscape.
Join Now!
Areas Covered
-
- Understanding Drug Regulations and the FDA’s Role: An overview of the U.S. FDA’s regulatory authority over new drugs, focusing on essential legal frameworks and compliance requirements.
- Navigating the NDA Process: Detailed guidance on the New Drug Application (NDA), including required data, submission protocols, and the FDA’s evaluation criteria for securing drug approval.
- Mastering the IND Process: Insights into the Investigational New Drug (IND) application and the exemption process for transporting investigational drugs across state lines, enabling effective multi-state clinical trials.
- Preparing for Production with Drug cGMPs: Essential information on Drug Current Good Manufacturing Practices (cGMPs) under 21 CFR 210/211, covering standards for drug manufacturing, quality control, and compliance.
- Addressing Key Areas of Concern: Identifying and managing common challenges in the NDA and IND processes, including regulatory hurdles, data requirements, and potential compliance risks.
- Understanding Post-Market Requirements: Overview of post-market compliance, monitoring, and reporting obligations to maintain FDA approval and ensure ongoing product safety and effectiveness.
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.
-
- Understanding Drug Regulations and the FDA’s Role: An overview of the U.S. FDA’s regulatory authority over new drugs, focusing on essential legal frameworks and compliance requirements.
- Navigating the NDA Process: Detailed guidance on the New Drug Application (NDA), including required data, submission protocols, and the FDA’s evaluation criteria for securing drug approval.
- Mastering the IND Process: Insights into the Investigational New Drug (IND) application and the exemption process for transporting investigational drugs across state lines, enabling effective multi-state clinical trials.
- Preparing for Production with Drug cGMPs: Essential information on Drug Current Good Manufacturing Practices (cGMPs) under 21 CFR 210/211, covering standards for drug manufacturing, quality control, and compliance.
- Addressing Key Areas of Concern: Identifying and managing common challenges in the NDA and IND processes, including regulatory hurdles, data requirements, and potential compliance risks.
- Understanding Post-Market Requirements: Overview of post-market compliance, monitoring, and reporting obligations to maintain FDA approval and ensure ongoing product safety and effectiveness.
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.
