Mini-Seminars

Readers of Get to Market Now! may be interested in viewing these free mini-tutorials (approximately 10-12 minutes each) on subjects in the book.  Each link below will open a new window through slideshare.net in which you can view the synchronized audio-visual slidecast.

For the various recorded compliance seminars referenced in some of the chapter “to-do” lists, see recorded seminars.

Conducting a Preclinical Stage Gate Review Session

Reviews:

  • Stage gate defined. Learn what a stage gate is and its usage in the new medicinal product development process.
  • Planning the review. Understand the 3 questions that the preclinical stage gate review must answer.
  • Assembling information inputs. See a sample list of the inputs required from 13 functions or departments.
  • Structuring the discussion to get results. Learn the 6 sub-topics around which to frame the meeting.
  • Pitfalls to Avoid. Recognize the 3 most common mistakes so you can avoid them.

Developing a Compliance Radar or Regulatory Intelligence Program

Covers:

  • Business power of regulatory intel. Top 7 reasons a compliance intelligence program is such an effective way to improve your bottom line.
  • Planning and implementation. The 6 steps to put in place an effective program.
  • Core elements. The 5 components of a compliance intelligence program.
  • Follow-up. How to build lasting value into your compliance radar.

Tips on What to Avoid in SOPs and Policies

Lays out:

  • Writing a policy or SOP. The 6-step process to better SOPs and policies.
  • Hidden purpose. Why SOPs and policies must also persuade, not just document.
  • Fatal errors. The 3 things to never, ever, ever put into an SOP.
  • Planning for compliance. The 4 most crucial questions to answer before crafting a single policy or SOP.

5-Slide Overview of the FDA Quality Systems Regulations

Discusses the following topics:

  • Requirements. The 2 most important requirements in the QSRs everyone in the company must know.
  • Underlying philosophy of enforcement. What the FDA is expecting to see and how you need to prove compliance.
  • Components. What the FDA expects from a quality system and what that looks like in the real-world.
  • What’s-in-it-for-me. How all of this impacts you and your day-to-day job.
To talk with the author about conducting an onsite workshop for your organization or speaking at your event, see scheduling a speaking engagement.