Puerto Rico’s FDA’s Regulatory Profile

DAVE CORTES, BSEE, PE W E B D A V E 2 0 0 0 @ G M A I L . C O M

W W W . 4 8 3 S U M M A R I E S . C O M /

P R O F E S S I O N A L E N G I N E E R ( P E )

P R O J E C T M A N A G E M E N T P R O F E S S I O N A L ( P M P )

C E R T I F I E D L E A N B L A C K B E L T ( L B B )

Puerto Rico’s FDA’s Regulatory

Profile

All Rights Reserved. Copyright 2012 by Dave Cortes

mailto:[email protected]

http://www.483summaries.com/

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Area Logistics

Training place

A / V usage

Exit routes

Rest rooms

Breaks

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Training Ground Rules

Attendance – In order to get credit for the training hours your presence is required throughout the duration of the training.

Electronics – The use of laptops / tablets is allowed since the material will be provided in electronic format. Nonetheless, its use cannot distract a peer.

Cell phones – It is important for cell phones to be in silent mode to avoid interruption. If call is critical please step outside to answer it.

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Training Ground Rules

Participation – Your involvement in the training is critical to your growth in the topic as well as it enriches the class. If you have examples or doubts related to the topic we are discussing please share.

Respect – There is a expectation of professional courtesy and respect among peers

Questions – There are no good or bad questions if you have it please interrupt. You are paying to have less doubts by the end of the training

Network – We will be seeing each other for a get to know each other

Have fun

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Expectations

What is your name?

Where do you work?

Industry type?

Do you have any prior experience / training in the topic?

What are your expectations for the course?

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My Journey

Dave Experience

•Achieved a Lean Black Belt with focus on Kaizen Events 2003.

• Become a Lean Black Belt in Pharmaceutical Industry in 2007.

•Then in 2009 the FDA started a surveillance process that resulted in a Corporate Wide Consent Decree to his manufacturing Operation.

•A burning Question blasted his mind: Why would the Quality Organizations could not foresee what was coming? Why where they so bad at predicting? He realized that the fact that the Quality Audits could not find the vulnerabilities was not evidence of a specific Audit weakness, but a limitation of all available Vulnerability Finding Systems in the Healthcare Industry.

•Then he asked a Question: Why would a $1 Trillion Healthcare Industry does not have a functional predictive Vulnerability finding model on their manufacturing operations?


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Agenda

1.0 Why your Quality is bound to fail? Complex Node Audits Inattentional Blindness Heuristic Bias In Audit Systems

2.0 Statistical Behavior of the FDA Survivorship bias on Regulatory Negotiations Statistical Behavior of the FDA

3.0 Statistical Behavior of FDA in Puerto Rico Statistical Behavior of FDA PR Observation Summaries

Conclusions Data Visualizations

Q&A

Slides

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“It Has Been More Profitable For Us To Bind Together In The Wrong Direction,

Than To Be Alone In The Right One.”

― NASSIM NICHOLAS TALEB

1.0 Why Your Quality Is Bound To Fail?

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If the FDA comes to your Operation today, there is a 54.1% of you receiving a 483 Letter of

Observations.

Why is this industry so bad a predicting its own vulnerability?


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PART 211 10

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL

PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PHARMACEUTICALS

Subpart A--General Provisions § 211.1 - Scope. § 211.3 - Definitions. Subpart B--Organization and Personnel § 211.22 - Responsibilities of quality control unit. § 211.25 - Personnel qualifications. § 211.28 - Personnel responsibilities. § 211.34 - Consultants. Subpart C--Buildings and Facilities § 211.42 - Design and construction features. § 211.44 - Lighting. § 211.46 - Ventilation, air filtration, air heating and cooling. § 211.48 - Plumbing. § 211.50 - Sewage and refuse. § 211.52 - Washing and toilet facilities. § 211.56 - Sanitation. § 211.58 - Maintenance. Subpart D--Equipment § 211.63 - Equipment design, size, and location. § 211.65 - Equipment construction. § 211.67 - Equipment cleaning and maintenance. § 211.68 - Automatic, mechanical, and electronic equipment. § 211.72 - Filters. Subpart E--Control of Components and Drug Product Containers and Closures § 211.80 - General requirements. § 211.82 - Receipt and storage of untested components, drug product containers, and closures. § 211.84 - Testing and approval or rejection of components, drug product containers, and closures. § 211.86 - Use of approved components, drug product containers, and closures. § 211.87 - Retesting of approved components, drug product containers, and closures. § 211.89 - Rejected components, drug product containers, and closures. § 211.94 - Drug product containers and closures. Subpart F--Production and Process Controls § 211.100 - Written procedures; deviations. § 211.101 - Charge-in of components. § 211.103 - Calculation of yield.

§ 211.105 - Equipment identification. § 211.110 - Sampling and testing of in-process materials and drug products. § 211.111 - Time limitations on production. § 211.113 - Control of microbiological contamination. § 211.115 - Reprocessing. Subpart G--Packaging and Labeling Control § 211.122 - Materials examination and usage criteria. § 211.125 - Labeling issuance. § 211.130 - Packaging and labeling operations. § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. § 211.134 - Drug product inspection. § 211.137 - Expiration dating. Subpart H--Holding and Distribution § 211.142 - Warehousing procedures. § 211.150 - Distribution procedures. Subpart I--Laboratory Controls § 211.160 - General requirements. § 211.165 - Testing and release for distribution. § 211.166 - Stability testing. § 211.167 - Special testing requirements. § 211.170 - Reserve samples. § 211.173 - Laboratory animals. § 211.176 - Penicillin contamination. Subpart J--Records and Reports § 211.180 - General requirements. § 211.182 - Equipment cleaning and use log. § 211.184 - Component, drug product container, closure, and labeling records. § 211.186 - Master production and control records. § 211.188 - Batch production and control records. § 211.192 - Production record review. § 211.194 - Laboratory records. § 211.196 - Distribution records. § 211.198 - Complaint files. Subpart K--Returned and Salvaged Drug Products

§ 211.204 - Returned drug products.

§ 211.208 - Drug produ

The Code has 11 Subparts,

enumerated from A to K. It is usually shown in this table form.

This Managerial visualization tool does not

give credit to the complexity inherent in this system.


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A More Effective Model

Quality Control Unit

Buildings and Facilities

Production and Process

Controls

Holding and Distribution

Laboratory Controls

Records and Reports

Returned and Salvaged

Drug Products

Packaging and Labeling Control

Control of Components and

Drug Product Containers and

Closures Equipment

A better way of visualizing the FDA Federal Code is as a Complex Node Diagram

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A Really Deep Model

If we Consider the 58 Sections of the Different Sub-Parts. The

possible combinations of the interactions can be stated as:

58 Factorial = 2.350 × 1078

This means that the Regulatory expectation of the Typical Pharmaceutical Manufacturing Management is that their people manage a system with

2.35E78 parts simply with their minds (not even a calculator).


Quality Control Unit

Equipment

Buildings and Facilities

Production and Process Controls

Holding and Distribution

Laboratory Controls

Records and Reports

Returned and Salvaged Drug

Products Packaging and

Labeling Control

Control of Components and Drug Product Containers and

Closures

Complexity of Applying The Regulation

How Regulatory Risk Can Be Effectively Identified In This Complex System?

Until Now The answer has been to do an evaluation of a random path of the system:

This is Called an Audit

Is this Enough with what is at stake?

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Complex Node Audits

Note that Audits behave as Path dependent

Processes, where a set of decisions one faces for

any given circumstance, is limited by the

decisions one has made in the past, even though past circumstances may

no longer be relevant.


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Let’s Complicate the Model a little bit more

And talk about:

“DETECTABILITY”


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Heuristic Bias In Audit Systems 19

Let’s test your BIASES.


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Answering something Easier 20

“When called upon to judge probabilities, people actually judge something else, and believe they have judge probability”

Daniel Kahneman, Thinking, Fast and Slow, 2011

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Examples 21

Target Question: How popular will Fortuño be the day of the election?

Substitution Question: How do I feel about Fortuño right now?

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“The Process-performance Paradox In Expert Judgment”. Camerer and Johnson, (1993)

“Behavioral Meta studies have shown that “expert judgments” are no more accurate than those of lightly trained

novices and expert judgment have been worse than the simplest

statistical models in virtually all domains.”


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“We have a deep problem when we are trying to manage a 18-

sigma system only with a unreliable biased mind.”

Dave Cortes


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Results of the current Method

Jim Prutow, a partner in the health care practice at the PRTM consulting firm, says of the Sanofi-Genzyme deal: “… regulatory actions including consent decrees are increasingly part of the cost of business...”* * Silverman, Ed, Sanofi Gobbles up Genzyme: What the Wags Say, Pharmalot 2/16/11.


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“Things Always Become Obvious After The Fact”

― NASSIM NICHOLAS TALEB

2.0 Statistical Behavior of FDA

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Statistical Behavior of FDA 26

What do you think is the worst bias in the industry relating to

its relation to FDA?

Let’s say: “Survivorship bias”


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Survivorship bias on Regulatory Negotiations

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Survivorship Bias is the logical error of concentrating on the people or things that "survived" some process and inadvertently overlooking those that didn't because of their lack of visibility.


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When Observations are answered to the FDA,

Companies only consider their own Data, because it is

known; but they do not consider the giant quantity of the same negotiation of other

companies.

MY COMPANY

PFIZER JOHNSON & JOHNSON HOFFMANN–LA ROCHE NOVARTIS

GLAXOSMITHKLINE SANOFI-AVENTIS ASTRAZENECA ABBOTT LABORATORIES

MERCK & CO. BRISTOL-MYERS SQUIBB ELI LILLY AND

COMPANY BOEHRINGER INGELHEIM TAKEDA

PHARMACEUTICAL CO. BAYER AMGEN GENENTECH BAXTER INTERNATIONAL TEVA PHARMACEUTICAL INDUSTRIES ASTELLAS PHARMA DAIICHI SANKYO NOVO NORDISK PROCTER & GAMBLE EISAI MERCK KGAA

ALCON SINOPHARM AKZO NOBEL UCB NYCOMED FOREST LABORATORIES SOLVAY GENZYME ALLERGAN GILEAD SCIENCES CSL CHUGAI PHARMACEUTICAL CO. BIOGEN IDEC BAUSCH & LOMB TAIHO PHARMACEUTICAL

. KING PHARMACEUTICALS WATSON PHARMACEUTICALS

MITSUBISHI PHARMA SHIRE CEPHALON DAINIPPON SUMITOMO PHARMAKYOWA

HAKKO SHIONOGI MYLAN LABORATORIES

H. LUNDBECK

The result is: Over and Under commitments that cost $$ Billions.


FDA

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Imagine a Baseball team choosing players knowing the statistics of their

own players only, and blind to the statistics of the other teams.

Imagine signing a $10 million contract blind of outside data. That is

exactly how a 1 Trillion dollar Industry answer the FDA everyday.

Baseball teams know better since the beginning of 20 century (and its

revenues are “only” $7B.)


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BIO-BREAK 10 MINUTES


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“Probability And Expectation Are Not The Same. Its Probability And Probability

Times The Pay Off.” ― NASSIM NICHOLAS TALEB

3.0 Statistical Behavior of FDA in Puerto Rico

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483 Form’s Sample

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Observations by sub-Part

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Observation by Section 38

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Statistical Behavior of FDA in Puerto Rico

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If Audits are path dependent events, then the starting point and the auditor preferences are critical to the outcome.


Auditors Behavior

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Summary: Top 5 Observations by Section

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Observation by Section 42

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Top 5 Observations by Section 43

1.0 “Production Record Review.”

2.0 “Responsibilities of the quality Control Unit”

3.0 Laboratory General Requirements

4.0 Equipment Cleaning and Maintenance

5.0 Sampling and testing of in-process materials and drug products

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Statistical Behavior of FDA in Puerto Rico: Examples

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1.0 “Production Record Review.”

Subpart J--Records and Reports Sec. 211.192 Production Record Review. All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.


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Top 5: #1: Product Record Review

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Statistical Behavior of FDA in Puerto Rico: 483 Observations

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DATE COMPANY TYPE

Order on

483 OBSERVATION

2-Nov-10

McNeil Consumer Healthcare

OTC Pharmaceutical Manufacturer 2

Written records of investigation into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusion and follow up.

3-Dec-10 Lilly del Caribe API Manufacturer 1

Your firm failed to perform an adequate and thorough investigations, invalidated results without scientific justifications, and to propose adequate CAPA of other batches for incidents related to out-of-specification and/or atypical events.

24-Feb-11 Mylan, LLC Drug Manufacturer 2

There is a Failure to throughly review any unexplained discrepancy and the failure of a batch or any of its componetns to meet any of its specifications whether or not the bactch has been already distributed.

28-Mar-11

Bristol-Myers Squibb Holding Pharma Drug Manufacturer 4

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

13-Aug-10

Bristol-Myers Squibb Holding Pharma Drug Manufacturer 1

There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.

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2.0 “Responsibilities of quality control unit.”

Subpart B--Organization and Personnel Sec. 211.22 Responsibilities of quality control unit. (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit. (c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. (d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.


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2.0 “Responsibilities of quality control unit.”

DATE COMPANY TYPE Order on 483 OBSERVATION

2-Nov-10 McNeil Consumer

Healthcare


The responsabilities and procedures aplicable to the qualily control unit are not in writing and no

fully followed.

4-May-10 Patheon Caguas Drug

Manufacturer 2


fully followed.

28-Jun-10

Ortho Pharmaceutical Manati

Drug Manufacturer 3

The responsibilities and procedures applicable to the quality control unit are not in writing and

fully followed.

28-Apr-11 Lilly del Caribe

API Manufacturer 1


fully followed.

28-Mar-11

Bristol-Myers Squibb Holding Pharma

Drug Manufacturer 1

The responsibilities and procedures applicable to the quality control unit are not fully followed.

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3.0 “Laboratory Controls, General requirements.” Sec. 211.160 General requirements. (a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified. (b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include:

(1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration. (2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified. (3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. Such samples shall be representative and properly identified. (4) The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.


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Top 5: #2: Laboratory Controls

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3.0 “Laboratory Controls, General requirements.”

DATE COMPANY TYPE

Order on 483 OBSERVATION

2-Nov-10 McNeil Consumer Healthcare

OTC Pharmaceutical Manufacturer 7 Established laboratory control mechanisms are not followed

28-Jun-10 Ortho Pharmaceutical Manati

Drug Manufacturer 2

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

24-Feb-11 Mylan, LLC Drug

Manufacturer 3

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

25-May-10 Bristol-Myers Squibb Manufacturing Company

Drug Manufacturer 3

determination of conformance to appropriate written specifications for the acceptance are deficient for in-process materials.

25-May-10 Bristol-Myers Squibb Manufacturing Company

Drug Manufacturer 7

The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.

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4.0 “Equipment cleaning and maintenance.”

Sec. 211.67 Equipment cleaning and maintenance.

(a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:

(1) Assignment of responsibility for cleaning and maintaining equipment;

(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

(4) Removal or obliteration of previous batch identification;

(5) Protection of clean equipment from contamination prior to use;

(6) Inspection of equipment for cleanliness immediately before use

(c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in 211.180 and 211.182


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Top 5: #3: Equipment

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4.0 “Equipment cleaning and maintenance.”

DATE COMPANY TYPE Order on 483 OBSERVATION

2-Nov-10 McNeil Consumer

Healthcare

OTC Pharmaceutical Manufacturer

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Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for protection of clean equipment from contamination prior to use.

4-May-10 Patheon Caguas Drug

Manufacturer 5

Written procedures are not established and followed for the cleaning and maintenance of equipment,including utensils, used in the manufacture, processing, packing or holding of a drug product.

28-Apr-11 Lilly del Caribe API Manufacturer 3

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

14-Mar-11 Abbott Pharmaceuticals

PR Drug

Manufacturer 4

Written procedures are not established and followed for the cleaning and maintenance of equipment,including utensils, used in the manufacture, processing, packing or holding of a drug product.

28-Mar-11 Bristol-Myers Squibb

Holding Pharma Drug

Manufacturer 5

Written procedures are not established followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

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5.0 “Sampling and testing of in-process materials and drug products.” Sec. 211.110 Sampling and testing of in-process materials and drug products.

(a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate:

(1) Tablet or capsule weight variation;

(2) Disintegration time;

(3) Adequacy of mixing to assure uniformity and homogeneity;

(4) Dissolution time and rate;

(5) Clarity, completeness, or pH of solutions.

(6) Bioburden testing.

(b) Valid in-process specifications for such characteristics shall be consistent with drug product final specifications and shall be derived from previous acceptable process average and process variability estimates where possible and determined by the application of suitable statistical procedures where appropriate. Examination and testing of samples shall assure that the drug product and in-process material conform to specifications.

(c) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality control unit, during the production process, e.g., at commencement or completion of significant phases or after storage for long periods.

(d) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.


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5.0 “Sampling and testing of in-process materials and drug products.”

DATE YEAR COMPANY TYPE Order on

483 OBSERVATION

2-Nov-10 2010

McNeil Consumer Healthcare


Written procedure are not followed that describe the in-process controls, tests, annd examinations to be conducted on appropriate samples of in-process materials of each batch.

4-May-10 2010 Patheon Caguas Drug

Manufacturer 3

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of.in-process material and the drug product

28-Mar-11 2011

Bristol-Myers Squibb Holding Pharma

Drug Manufacturer 3

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

25-May-10 2010

Bristol-Myers Squibb Manufacturing Company

Drug Manufacturer 1

Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

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“It Does Not Matter How Frequently Something Succeeds If Failure Is Too

Costly To Bear” ― NASSIM NICHOLAS TALEB

Conclusions 57


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Summary of the Proposed Model 58

RISK = Vulnerability x Threat x Cost Regulatory Risk(Plantx_) =Vulnerability(Plantx_) x FDA Alertness x Event Cost(Plantx_)

CURRENT MODEL PROPOSED MODEL

Risk Not considered in the model. Model centered on internal vulnerability,

not risk.

Statistic model Based on Vulnerability, FDA Alertness, and

Event Cost

FDA Alertness Not considered in the model, Mostly informal anecdotal links.

FDA Statistics is core part of the Model.

Vulnerability Focused on Expert Judgment’s Audits to the CODE.

Complement current model with Systemic Statistic Models and

Industry wide Baselines comparisons.

NOTE that It's not Threat, Vulnerability Or Cost alone that really matters, but REGULATORY RISK. As you can see from the risk equation, to be any risk there

must be at least some threat, vulnerability and cost.


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Thank You!

Q&A

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Evaluation

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Puerto Rico’s FDA’s Regulatory Profile

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