Combination Drug/Device Products CGMPs - Final Rule
- Speaker:Dr. David Lim
- Product Code:GRC-90151
Live Session - How it works
- Username and Password will be sent to you within 24 hours prior to the webinar.
- Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
- Login to the session by clicking on “Join the Meeting” in the login instructions and then dial the number to connect to the meeting audio or use your Computer to connect to audio. Please use the name and the email address you used at the time of registration to join the meeting.
- Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
- Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve our Training programs.
- Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our firstname.lastname@example.org
Recorded Session - How it works
- Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
- Please click on the link to access the Recording and type in the password provided in the email.
- Presentation and other handouts will be emailed to you in a pdf format.
Training CD - How it works
- Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
(For more information about our products contact +1- 248-233-2049)
This webinar will discuss the US’s FDA Final Rule for current Good Manufacturing Practices (CGMPs) for combination products. In particular, it is intended to better understand the cGMP requirements for enforcement purposes.
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). The speaker 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, do design controls apply when a device constituent part is used in a combination product? If so, what levels of design control would apply?
To achieve compliance and to remain compliant with the cGMP requirements applicable for combination products, it is critical that executives and managers understand and accurately interpret the applicable requirements so that compliance to cGMP requirements can be adequately, sustainably achieved.
This webinar will provide a great opportunity to get familiar with the cGMP requirements and greatly improve your awareness and confidence.
Areas To Be Covered in this Seminar:
• Applicable Laws and Regulations
• Current Good Manufacturing Practice (cGMP) Final Rule 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 to Biological Product and HCT/P Requirements
• Comparative Discussion on 21 CFR Parts 210/211, 600-680, 820, and 1271
• Common Misconceptions
• How to implement cGMPs for Combination Products
• Best Practices: Dos and Don’ts
• Speaker’s PASS-IT Recommendations
Who will benefit:
• Compliance Officers
• Regulatory Affairs
• Clinical Affairs
• Quality Assurance
• Anyone Interested in the FDA Drug Review and Approval Processes
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.
Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.