The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices

  • Speaker:Dr. David Lim
  • Date: 31st May 2018 10:00 AM PST | 01:00 PM EST
  • Duration:60Min
  • Product Code:GRC-90318

$169

10

DAYS
Left to Register

refer

Refer Friend's


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve.
  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.

Description:

It is of paramount importance to design, validate and control water systems used in the manufacture of drugs, biologics and medical devices. 

This presentation is intended to discuss FDA requirements for water systems from a microbiological aspect for drugs, biologics and medical devices.  In particular, it is intended to discuss microbial control, monitoring and validation of water systems. 

This presentation will provide great opportunities for industry professionals to be better aware of and rather get more familiar with the FDA’s expectations for establishing water systems suitable for use in the manufacture of drugs, biologics and medical devices.

Areas To Be Covered in this Seminar:

  • Applicable Laws and Regulations
  • Definitions
  • Types of Medical Products
  • Key Considerations for Designing a Water System
  • Types of Water Used in the Manufacture of Drug Products
  • Different Types of Water Required for Different Types of Products
  • Water System Design: Acceptable Methods
  • Types of Water Required for Inhalation, Ophthalmic or Parenteral Products, etc.
  • What to Consider for Water System Validation
  • Water System Validation
  • Common Problems
  • Microbial Control for Different Types of Water
  • Acceptance Criteria
  • Water Sampling
  • PASS-IT Recommendations

Who will benefit:

  • Professionals in Healthcare Industry: Drugs, Biologics, Medical Devices/Ivds, Combination Products, Etc.
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Compliance Officers
  • Radiation Safety Officers
  • Laboratory Personnel
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Other Professionals Interested In This Topic

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor.  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 seven 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.

Available Options

Live Meeting Access Single: Attend the meeting Live via Webex Meeting

$169

2 Single Live Access: 2 people can attend the meeting Live from any location

$279

3 Single Live Access: 3 people can attend the meeting Live from any location

$349

Recording: Access the training Recording for 6 months from any location

$259

CD: Shipped within 2 working days

$359

USB - Shipped within 2 working days

$389

Live + Recording: Attend Live Meeting Online + Access the recording for 6 months

$289

Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

$389

Live + USB - Attend Live online + Get the training USB shipped for free

$409

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$549

10 Member group: 10 can Attend Live Meeting Online from any location globally

$849

Related Products

510(K) Submission - A Comprehensive and an Updated Overview

510(K) Submission - A Comprehensive and an Updated Overview

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Why should you attend:The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical ..

$289

Validation and Control of Excel Spreadsheets in Regulated Environments

Validation and Control of Excel Spreadsheets in Regulated Environments

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 1..

$279

Implementing a (UDI) Unique Device Identification System

Implementing a (UDI) Unique Device Identification System

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Description: This webinar will discuss the regulatory and compliance requirements to implement a system for Unique Device Identification (UDI) including final rules, compliance dates and requirements. The speaker will walk you through the requirements including, but not limited to, what to con..

$279

Root Cause Analysis and CAPA

Root Cause Analysis and CAPA

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from..

$279

FDA Requirements for Computer System Validation

FDA Requirements for Computer System Validation

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software an..

$289

Validation of Analytical Methods according to the New FDA Guidance

Validation of Analytical Methods according to the New FDA Guidance

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. Description:FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The guidan..

$279

Combination Drug/Device Products CGMPs - Final Rule

Combination Drug/Device Products CGMPs - Final Rule

Description: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..

$179

Requirements of Validation – IQ, OQ and PQ Protocols

Requirements of Validation – IQ, OQ and PQ Protocols

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:Validation is an important element of the Quality System Regulations and ISO13485.   This course will cover the requirements the essentials of validation.  You’ll learn about what processes needed to be validate..

$289