Combination Drug/Device Products CGMPs - Final Rule

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Length
60 minutes
Product Description

Understand the FDA’s Final Rule for cGMPs for Combination Drug/ Device Products

To achieve compliance and to remain compliant with the applicable cGMP requirements for combination products, it is very crucial for executives and managers to understand and accurately interpret the applicable requirements so that compliance to cGMP requirements can be adequately and sustainably achieved. The current Good Manufacturing Practice (cGMP) requirements for combination products are set forth in 21 CFR Part 4.

This conference by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA is intended to discuss US FDA Final Rule for current Good Manufacturing Practice for combination products.  In particular, it is intended to talk about what every executive and senior manager must know. 

Both domestic and foreign manufacturers are required to establish and maintain a quality management system (QMS) to the extent applicable for combination products (e.g., drug and medical device).  David will discuss how firms can achieve compliance with quality system regulations as well as how to achieve compliance with drug cGMP requirements for combination products.  For example, when a device constituent part is used in a combination product, do designs control apply?  If so, what levels of design control would apply (e.g., design history file)?

This session will provide great opportunities for executives and managers to become actionably familiar with the current good manufacturing practice requirements applicable to combination products. It will ensure improved awareness including the importance of achieving compliance to the applicable requirements to each product constituent.  

Session Highlights:

  • Applicable Laws and Regulations
  • Key Terms
  • Current Good Manufacturing Practice (cGMP) Requirements for Combination Products
  • cGMP Requirements for a Co-Packaged or Single entity Combination Product
  • Implementing Compliance to Quality System Regulations
  • Implementing Compliance to Drug cGMP Requirements
  • Implementing Compliance with Biological Product and HCT/P Requirements
  • Comparative Discussion on 21 CFR Parts 210/211, 600-680, 820, and 1271
  • Common Misconceptions
  • Adequate Implementation of cGMPs
  • Best Practices: Dos and Don’ts
  • Speaker’s PASS-IT Recommendations

Who Should Attend

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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