FDA Regulatory Course Description

This course is designed to provide participants with an up-to-date understanding of the drug and biotech requirements for FDA regulatory compliance, successful approaches to compliance, and strategies for meeting the concerns of regulators. Attendees will leave with a comprehensive understanding of FDA drug regulations and be prepared for the upcoming changes to the International Council for Harmonization(ICH) Good Clinical Practice (GCP) E6 requirements in the US. The ICH E6(R3) Draft has been released for early consultation and the important changes are covered in this course.

Additional benefits of this FDA Regulatory Compliance class include:

  • FDA inspectional authority and processes including 483s, Warning Letters, recalls, and other potential actions
  • The role of clinical data in supporting product approval
  • FDA Quality by Design initiatives
  • Update on FDA electronic submission requirements
  • The benefits of a quality management system beyond the manufacturing environment

Agenda

First Day

Session 1 : 11 am -01:00 pm EDT

1. Introduction

  • FDA delegated authority and powers
  • FDA compliance: regulations, guidelines, internal agency controls
  • FDA enforcement
  • 483s
  • Warning Letters
  • Consent Decrees
  • Seizure
  • Recalls

2. Interpreting Regulations

  • Review of applicable regulations
  • FDC ACT
  • CFR
  • Establishing clear criteria
  • Establishing clear SOPs and policies
  • Managing the process

20 minutes Break

Session 2 : 1:20 -03:00 pm EST

3. Audits and outsourcing

  • Auditor qualifications
  • Use of contract support
  • Internal auditing procedures and schedule
  • Key critical audit areas
  • Audit expectations of site personnel
  • Staff training

20 minutes Break

Session 3: 03:20 - 05:00 PM EST

4. Management Oversight

  • Quality Policy
  • Management Review
  • Escalation of issues to upper management
  • Communication, decision making and transparency across management
  • Resourcing

Session End time : 5 pm EST

Second Day

Session 1: 11:00 -12:30 PM EST

5. Navigating FDA

  • Website Review
  • Investigator Operations Manual
  • Compliance Policy Guides and Program Manuals

6. Emerging Trends at the FDA

  • New compliance issues
  • Drug shortage crisis
  • Counterfeit drug issues and growing concerns
  • Biosimilar approval pathways

15 minutes Break

Session 2: 12:45 - 03:00 PM EST

7. Drug Development and Approval Process

  • Drug Development
  • QbD product development and design
  • Risk analysis
  • Post approval changes to process, methods etc.
  • Regulatory Filings
  • Key elements of IND, NDA/ANDA applications and FDA expectations
  • Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway)
  • FDA Review and Approval Process
  • Post Approval Submissions

20 minutes Break

Session 3 : 03:20-05:00 pm EST

8. Successful Approaches to Compliance

  • Internal Auditing Procedure and Schedule
  • Gap Analysis
  • Regulations, Guidances and Procedures
  • Remediation Plan
  • CAPAs
  • Change Control Process
  • Assignment of resources to correct issues
  • Training Procedure and Curriculums
  • FDA communication
  • Direct communication (emails,phone calls)
  • Recalls
  • Post approval submissions – annual reports, ADE reporting

9. Summary

  • Key Issues
  • Questions and resources

Session End time : 5:00 PM EST

Who Should Attend from this FDA Training

This regulatory compliance course is designed to provide attendees with a strong foundation for understanding the drug and biotech regulatory requirements of the US FDA. The content is ideal for those looking for an introduction to regulatory compliance or who need a refresher on current compliance trends within the regulated environment.

Typical attendees include those in the following disciplines:

  • Regulatory Affairs
  • Manufacturing/Production
  • Research and Development
  • Quality Assurance & Control
  • Development and preparation of submission material

This course is ideal for new hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. All levels of experience will benefit from this course.

Choose a Purchase Option


$1,595

One Dial-in One Attendee - Live + 90 days Access

Early Bird $1595 Regular Price $2095

You get one log-in for the live virtual seminar for one participant & On Demand Recorded Access for 90 days , presentation materials , Certificate and the opportunity to ask questions by phone and email.

$3,995

Group-Max. 5 Attendees - Live + 12 month Access

You get Group log-in for the live virtual seminar for 5 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 12 months for the Group.

$3,998

Recorded Access Group

You'll have 12 month access to group log-in for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Faculty Karl M. Nobert (25+ yrs exp)

Senior Counsel Michael Best & Friedrich LLP - USA

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics, vitamins and dietary supplements, and veterinary products.

He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.


Our Past Seminar Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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