FDA Regulatory Compliance For Drug And Biotech Product Training Course  (ONLINE EVENT: December 2-3, 2024/ON-DEMAND)
FDA Regulatory Compliance For Drug And Biotech Product Training Course  (ONLINE EVENT: December 2-3, 2024/ON-DEMAND) . (MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Product Training Course" training has been added to ...
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(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Product Training Course" training has been added to ResearchAndMarkets.com's offering.

This course will benefit professionals involved in working with and Biotech products and management involved in drug development and FDA Regulatory Compliance.

Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act.

In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for manufacturing, testing and control of clinical supplies and commercial products.

12.0 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend:



QA/QC analytical chemists

QA/QC directors, managers

Investigators in QA/QC

Manufacturing/Production

Research and Development

Project management

Manufacturing personnel

CROs analysts

Technical liaison

Regulatory affairs personnel

CMC specialists

Senior quality managers

Quality professionals

Regulatory professionals

Compliance professionals

Quality auditors

Document control specialists New hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.

Day 1

FDA and its Statutory and Regulatory Requirements

FDA's Structure and Purpose



The Federal Food, Drug and Cosmetic Act

The Code of Federal Regulations

Guidance, Policy Documents and Compliance Manuals The Evolution of FDA Law

Brief Overview: The Products FDA Regulates and Their Pathways to Market



Drugs

Medical Devices

Food & Dietary Supplements

Cosmetics

Tobacco Veterinary Products

Universal Requirements

Establishment Registration, Product Listing, User Fees, etc.

FDA Drug Development and Approval Process Considerations



Statutory and Regulatory Provisions

Citizen Petitions

Approvals and Clearances



The Drug IND, NDA, ANDA and Orphan Designation



Biologic's BLA



Medical Device 510(k) and PMA



Combination Products

Veterinary INAD, NADA, ANADA, MUMS

FDA Drug Approval Process



Case Study #1: Suitability Petitions

Case Study #2: Paragraph IV Certification

Post Approval Submissions

QbD product development and design

Key elements of IND, NDA/ANDA applications and FDA expectations

Electronic CTD format and content, most submitted through ESG (Electronic Submissions Gateway)

Post-approval changes to process, methods etc.

Regulatory Filings Risk analysis

Statutory and Regulatory Compliance



The Concepts of "Adulteration" and "Misbranding"

Identifying Non-Compliance



Product Label and Labeling



The Internet



Approval and Clearance



Facility Inspections



Adverse Events



Recalls

Trade Complaints and Anonymous Tips

FDA's Compliance Options, Historical Case Examples & FDA's Website



Form 483s



Untitled Letters



Warning Letters



Import Alerts



Seizures



Recalls



Consent Decrees



Temporary and Permanent Injunctions



Civil and Criminal Prosecution

The Park Doctrine

Other Compliance Bodies DOJ, FTC, EPA, the States, NAD

Management's Role and Responsibilities in Compliance



Communication, Implementation and Decision Making

Quality Policy and Resourcing

Personnel Training Escalation of issues to upper management

Corrective and Preventive Actions (CAPA)

Gap Analysis

Facility Audits and Inspections



Internal Company Audits



Training the Employees



Use of Third-Party Auditors



Auditor qualifications understanding



Learn Key critical audit areas



Internal auditing procedures and schedule

Supplier and Customer Audits

FDA Inspections

Foreign Inspections

The FDA Form 483

Strategies for Successfully Responding to a Form 483 including Inspection Observations and Violations



The Written Response



Communication with FDA

Disagreements with Form 483 Observations When the Form 483 Becomes a Warning Letter

Day 2

Manufacturing and Quality Controls for Drug Products



Management's Role and Involvement

Complying with Good Manufacturing Practices "cGMPs"

Laboratory Quality Controls

Standard Operating Procedures



What Makes a Good SOP



How to Write an Adequate SOP Strategies for Drafting

Recalls and Market Withdrawals



FDA Jurisdiction and Authority

Stock Rotations

Corrections

Market Withdrawals

Recalls



Recall Classifications



How to Conduct a Product Recall



Customer Communication



FDA Communication

Documentation Strategies for Mitigating the Chances of a Recall

Pharmacovigilance



Definitions of Significant and Serious Adverse Events

Recording, Investigating and Reporting Complaints

FDA Communication Strategies for Dealing with Complaints

Customs, Detentions and Import Alerts



The Process

Holds and Detentions

Seizure and Destruction

Remediating The Import Alert

Rx Drug Promotion and Advertising



Risk Considerations



"Fair Balance"



Elements & Considerations





Brief Summary





Boxed Warning

Important Safety Information

False and Misleading Claims



Fair Balance



Superiority Claims



Testimonials



Market Research



Quality of Life Data

Other Considerations Enforcement Action Examples

Emerging Compliance Trends



Counterfeit drug issues and growing concerns

Drug shortage crisis

Biosimilar approval pathways Others

Other Compliance Issues

Questions & Answers and Closing Thoughts

Speakers:

Karl M. Nobert

Michael Best & Friedrich LLP

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.

For more information about this training visit

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2024-11-08
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(MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "FDA Regulatory Compliance for Drug and Biotech Product Training Course" training has been added to ...
FDA Regulatory Compliance For Drug And Biotech Product Training Course  (ONLINE EVENT: December 2-3, 2024/ON-DEMAND)