Webinar Recordings

Validation, Change Control
and
Maintaining the Validated State

May 23, 2018

Gamal Amer

Ph.D., Principal, Premier Compliance Services, Inc.

Managing changes in your Quality Management System is a FDA regulatory requirement. Change control is used as a risk mitigation tool and to maintain a validated state-of-control. This webinar guides you through a process of developing, implementing and maintaining a robust change control program enterprise-wide.

Implement a Holistic Data Integrity Assurance Plan – From Data Creation to Retirement

June 26, 2018

Chinmoy Roy

Data Integrity and CSV SME

While Data Integrity continues to occupy the top spot in C-suite issues, issuance of 483 and Warning Letters continues unabated. The prime cause for this is the inability of companies to address Data Integrity holistically. No longer can companies afford to view this issue as confined to a few areas of their operation. Instead, it needs to be viewed as a process-centric issue that spans the realm from data creation to data retirement as the data progresses from its point of creation to the point of its use and ultimate storage. 

Process Validation Statistics for Non-Statisticians

July 25, 2018

Tara Scherder, Partner, SynoloStats

Katherine Giacoletti , Partner, SynoloStats

Process understanding and risk management are essential to the Lifecycle Approach to Process Validation, and statistical thinking is a key enabler to both. This webinar presents common statistical methodologies used for process design (Stage 1), performance qualification (Stage 2), and continued/ongoing process validation (Stage 3).

Implementing Risk Management
in the Validation Process

August 31, 2018

Gamal Amer

Ph.D., Principal, Premier Compliance Services, Inc.

In this webinar, the concepts associated with Quality Risk Management as outlined in ICH Q9 Guidance and the importance of the Risk Priority Number (RPN) are discussed. This knowledge will then be applied to decision making in prioritizing and defining the extent of qualification necessary based on the concepts advanced in the FDA’s Guidance on Process Validation of January 2011.

The Validation Master Plan (VMP)

September 26, 2018

Gamal Amer, Ph.D.

Principal, Premier Compliance Services, Inc.

A VMP describes aspects for qualifying your facility, including written procedures for equipment and systems validation and maintaining the qualified state. FDA’s Guidance suggests that Process Validation is a three-stage approach and Stage 2 requires proper qualification of the process and facility prior to conducting a Process Performance Qualification (PPQ). This webinar defines what you now need to do to develop the right VMP that complies with FDA’s current expectations.

Data Integrity by Design – A PROACTIVE Approach

October 31, 2018

Steve Thompson, Senior Manager, Professional Services, ValGenesis

There is a lot of available information on data integrity but most, if not all, is focused on reactive measures. Ideally organizations will become proactive and thus avoid problems altogether. This presentation is unique because you’ll learn how to proactively design data integrity into your systems now and avoid problems later.

Yes, data integrity is on the regulatory radar and inspectors are now including this as part of their inspections. However, data integrity it nothing new especially as it relates to information technology and computer science. This webinar provides insight on how a good technology solution may, in fact, help you prove your organization, by the very systems they use, are ensuring data integrity. You also gain insight on how you can identify potential gaps and effectively mitigate them. Finally, you’ll be equipped to identify assess new technologies your planning to procure to determine if the technology solution provider has made data integrity integral to their design.

Cybersecurity, Data Integrity & Validation – Addressing Malicious Threats to the Life Science Industry

November 30, 2018

Steve Thompson

Senior Manager, Professional Services, ValGenesis, Inc. – South San Francisco, CA

Part 1 – Understand Malicious Threats and Attack Vectors
• Learn how attackers attack from the outside
• Once inside, understand their methods to maximize damage
• Understand why they’re motivated to wreak havoc
• Learn how Data Integrity can be jeopardized
• Know the potential costs to your organization
• Shed light on the dark side

Part 2 – How to Protect, Detect, and Remediate Attacks
• Is protection futile?
• What are the best ways to detect attacks?
• Have I already been attacked and, if so, how do I know?
• What do I do if there’s a breach
• Does Validation secure and protect systems?
• How can I successfully remediate an attack?

Knowledge Exchange
Attendees walk away with answers to the bulleted questions in Parts 1 and 2. An open-exchange allows attendees to share their experience with:
a) Attacks encountered;
b) Responses;
c) Lessons learned.

Takeaway Tools
• A cybersecurity check-list
• A list of useful terms, definitions and resources 

Using Risk to Guide Implementation of Quality System Elements

December 19, 2018

Gamal Amer, Ph.D.

Principal, Premier Compliance Services, Inc.

Risk is always present in every human endeavor. Managing risk to the quality of pharmaceutical products which translates to risk to the patient is the main concern of cGMP. The presentation will discuss the concept of risk levels and then identify quality system elements as identified by ICH 10 and how these are used to manage and mitigate the risk to the quality of the products.

We will discuss:
– Quality System Elements and the risk mitigation processes
– Implementation of process and product risk mitigation through the quality system elements
– How process performance and product quality improvement are achieved by implementing the Quality System Elements.