We work with a few of the top industry training companies and also now offer our own unique professional development workshops to industry professionals. We facilitate tailored inhouse workshops as well. All of our workshops are designed to support the development and implementation of solid, risk-based pharma and biotech compliance strategies.

Ongoing

Clinical Leader Articles by Penelope Przekop

Articles

Event Details

Ongoing

Articles

25 June 2019

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

1:00 PM EST - 2:30 PM EST

Webinar

Event Details

25 June 2019

Developing Practical and Successful GCP and GVP Audit & Inspection CAPAs

This webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges.  Go here to learn more and register.

1:00 PM EST - 2:30 PM EST

Webinar

18 July 2019

How to Establish & Maintain a Compliant, Practical Clinical QMS in a Changing Organization

1:00 PM EST - 2:30 PM EST

Webinar

Event Details

18 July 2019

How to Establish & Maintain a Compliant, Practical Clinical QMS in a Changing Organization

Attend this webinar to gain practical solutions to establish a basic, compliance QMS that will include the following key ingredients. Go here to learn more and register.

1:00 PM EST - 2:30 PM EST

Webinar

22-23 July 2019

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

All day

2 Days in San Francisco

Event Details

22-23 July 2019

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

This 2-day in-person course will be  provided through ComplianceOnline/MetricStream. Go here to learn more and register.

All day

2 Days in San Francisco

Ongoing

Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs

Recorded Webinar

Event Details

Ongoing

Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs

This live webinar was provided in April 2019 through the Life Science Training Institute. Go here to learn more and register for the recorded Webinar.

Recorded Webinar

More Events
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Pharmacovigilance (PV) Auditors are Like Gold!

Join our 4.5-day intensive, tailored workshop for Experienced GCP Auditors

This 4.5-day intensive training workshop will provide 8 experienced GCPs auditors with the knowledge, tools, and insight required to successfully use their transferable knowledge, experience and skills to move into the PV quality assurance and compliance space. Our aim is the make this the best PV auditing course available in the industry. It will include hands-on mock auditing activities and a certification of completion. It will be based on common sense and risk-based decision making ... and it will be fun! The first session will take place this fall in Philadelphia. Registration to open soon.


Why is the course limited to 8 attendees? Limiting this workshop to 8 GCP auditors supports our vision of providing a tailored, personal learning experience that will include conversation among like-minded professionals in addition to classroom learning, hands-on exercises, and group and personal mentoring. Upon completing the workshop, each GCP auditor will also receive an hour of one-on-one Skype mentoring with Penelope Przekop. Penelope will work with each auditor on how they can best address their specific goals and/or challenges as they move into the PV space, whether as a permanent employee or consultant. Although the workshop will include the topics below, it will be tailored to the attendees to ensure that no time is wasted and each attendee feels confident as possible about PV auditing when they complete the workshop. To this end, attendees are required to provide their professional CV to us and to participate in a 30-minute call with Penelope Przekop in advance of the workshop.

Join our interest list below. Of note, we've had inquiries regarding a similar workshop for PV Auditing for PV Operations Professionals. If this interests you, please email us at info@pdcstrategy.com

Workshop Attendee Requirements

At least 5 years of GCP auditing experience


Provision of your professional CV to us upon registration. Your CV should be sent to  info@pdcstrategy.com (we need this to tailor your experience)


Participation in 30-minute phone conversation with Penelope Przekop prior to the workshop.This meeting should ideally occur soon after registration to ensure the best possible workshop experience. 


A positive attitude and interest in helping to develop a team rapport throughout the week that can remain a great ongoing professional network.


A willingness to take spotcheck quizzes throughout the workshop and discuss results with the team.


Completion of a feedback survey at the end of the course to help with our continuous improvement goals.


Interest in having a 1-hour post-workshop mentoring call with Penelope Przekop for the purposes of allowing her to assist with your specific goals/challenges as you move into the PV auditing space.

What Will Eight Experienced GCP Auditors Gain?

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Global Clinical and Post-Marketing Pharmacovigilance (PV) Regulatory Authority Requirements

Laying the Foundation: The first 1.5 to 2 days of the workshop will focus on global PV regulations, guidance, and expectations. The spotlight will be on those most commonly audited against; however, others related to more specific nuances such as FDA REMS, devices, product complaints, and biologics will also be discussed. The amount of time spent on each topic will be based on review of the attendee CVs and a 30-minute pre-workshop telephone discussion.  

Global Regulatory Authority and Industry Standard Expectations and Common Practices for PV

Understanding the Risks and Using Common Sense: Throughout the first two days, as we cover global regulatory authority regulations, etc. we'll also focus on risk-based approaches and best practices that impact our industry and PV auditing practices. This includes consideration and discussion on how regulators and the industry expect regulations to be interpreted and applied. 

How to Identify and Apply Your Transferable Knowledge, Experience and Skills to PV Auditing

Transferring Your Skill Set: As an experienced GCP auditor, you've amassed a valuable skill set. At least half a day will be spent on instruction, discussion and mentoring to assist attendees with understanding how elements of their established skill set  can be applied to PV auditing. Each attendee will identify their specific transferable skills and knowledge and how they can be applied to PV auditing. To ensure best results for this session, it's important that each attendee provide their CV in advance of the workshop.

How to Plan, Structure, and Execute a PV Audit

The PV Audit: After an initial focus on PV Audit planning, a significant amount of time will be spent moving through a typical PV Audit agenda. Each "agenda" session will be a learning experience on how to conduct the session, what should be requested, reviewed, explored, evaluated, etc. Each session will be dovetailed with the topics noted above to provide a comprehensive understanding of PV auditing. Specific typical scenarios as well as real world examples will be shared and discussed.  Auditing exercises will be sprinkled in to provide hands on learning experiences.    

How to Respond to Challenges Inherent in Broadening Your Auditing Services

Anything Worth Having is Worth Working For: In this session, we'll acknowledge and discuss the challenges inherent in moving into the PV space. How can you get your first PV auditing assignment if you haven't yet conducted a PV audit? How should you structure your CV? How do you get started? How can you best answer typical questions that will be asked when talking with decision makers about your ability to conduct a PV audit? All these questions and more will be addressed. Specific, actional suggestions, tips, and tactics will be provided to support your move into the PV auditing space. At the end of this session you should feel confident that you can do this!  This session will also be tailored for those in attendance, considering their current employment status (permanent employee vs. consultant) and goals.  

PV Auditing for GCP Auditors Interest List

Let us know if you're interested in our 4.5-day intensive workshop for experienced GCP Auditors.