Displaying 1–25 of 58 results for Ali Afnan

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January 2013

January 2013

Can FDA Walk the Talk on Standards?

(Article)

FDA’s Office of Product Quality needs a change agent. Ali Afnan has a suggestion.

FIP Announces IPS Medal Winner

(News)

International Pharmaceutical Federation honors Dr. Ali Afnan for his contribution to global pharmaceutical industry

FDA, Revisit Your Sampling Guidance!

(Article)

Why are we so comfortable following draft guidance—FDA’s unfinished and incomplete current thinking?

Afnan: Biopharm: Thinking Too Linearly?

(Article)

The idea that “the product is the process and the process is the product” can either result in sameness, or true control.

Therapeutic Dose: Who's on First?

(Article)

When it comes to QbD, we keep using that word, but does it mean what we think it means?

Afnan: Channeling Don McLean

(Article)

Standard work definitions, and recognized standards, will improve drug manufacturing—not nostalgia, or the insistence that “pharma is different.”

Afnan: Stepchange: A Rap on the Head

(Article)

Wishing won’t move pharma from a tribal to a diverse, crossfunctional culture.

Therapeutic Dose: Sampling: Good News, Bad News

(Article)

Changing from the status quo to meaningful testing will satisfy both FDA and ASTM.

November/December 2011

November/December 2011

Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the ...

(Article)

Effective change must improve business performance, and not just a process.

Afnan: Scientific Sampling

(Article)

Process knowledge demands a very different approach to sampling.

Afnan: Drug Shortages and Accountability

(Article)

Is an overly rigid FDA causing today's chronic drug shortages? Or is it an industry that still struggles to meet the most basic quality standards?

Afnan's Letter from Japan: Japanese Pharma's Embracing PAT, QbD and Opex Tools

(Article)

As its auto industry has done, Japan pharma may demonstrate that a cheaper manufacturing base is not necessarily the solution to our problems.

Afnan: Will Biopharma Dare to be Innovative?

(Article)

Three-to-four-month flu vaccine manufacturing cycles are within reach.

April 2011

Ali Afnan: Process Validation: Can We Now Get Back to Basics?

(Article)

FDA’s new guidance on process validation gets back to the original language of the GMPs on the subjects of control and sampling, Ali Afnan writes. After all, FDA never intended for three consecutive batches to satisfy either the spirit or the letter of the law.

Focus on Pharma Episode 15: Straight Talk on FDA's New Process Validation ...

(Multimedia)

It will add to the complexity and cost of compliance, in the short term, says one of the guidance's authors, but will offer tremendous savings in the cost of quality, time to market, cost of stockpiled product, and cost of filing process revisions with FDA.

From the Editor: Why Can’t Pharma Think More Like Chem?

(Article)

Using physical material attributes allows for much tighter control of processes and product quality. Could a new excipient database be a model for pharma?

Real-Time Release: It’s Time for Action, Not Debate

(Article)

Before arguing about Just in Time (JIT) solutions and how to define them, shouldn’t we look at why we need them, and form a plan?

Onsite and Online, Interphex Attracting Visitors

(Article)

The annual spring tradeshow has reenergized itself by building a year-round online presence.

Crazy Like a Fox

(Article)

New paradigms are needed if PAT’s promise is to be realized for biopharma process control.

Therapeutic Dose: It Seemed Like a Good Idea at the Time

(Article)

Saving money through outsourcing is really starting to cost us.

Ali Afnan: Bridging Pharma's Innovation Divide

(Article)

Could closer study of Lean performance, supplement approval, and GMP oversight reveal correlations and drive holistic innovation, and cultural change?

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